betamethasone dipropionate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
prednisone and prednisolone derivatives	353	5593-20-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: betamethasone dipropionate diproderm diprosone	A glucocorticoid given orally, parenterally, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. Its lack of mineralocorticoid properties makes betamethasone particularly suitable for treating cerebral edema and congenital adrenal hyperplasia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p724) Molecular weight: 504.60 Formula: C28H37FO7 CLOGP: 3.92 LIPINSKI: 1 HAC: 7 HDO: 1 TPSA: 106.97 ALOGS: -5.04 ROTB: 8 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

betamethasone dipropionate
diproderm
diprosone

A glucocorticoid given orally, parenterally, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. Its lack of mineralocorticoid properties makes betamethasone particularly suitable for treating cerebral edema and congenital adrenal hyperplasia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p724)

Molecular weight: 504.60
Formula: C28H37FO7
CLOGP: 3.92
LIPINSKI: 1
HAC: 7
HDO: 1
TPSA: 106.97
ALOGS: -5.04
ROTB: 8

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

Property	Value	Reference
S (Water solubility)	0.06 mg/mL	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
Jan. 29, 1975	FDA	SCHERING

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Macular degeneration	503.37	16.66	171	8715	24205	63455931
Psoriasis	257.84	16.66	157	8729	86800	63393336
Drug ineffective	128.38	16.66	376	8510	1044389	62435747
Chronic sinusitis	95.41	16.66	43	8843	12800	63467336
Product use in unapproved indication	91.93	16.66	119	8767	178961	63301175
Paraesthesia oral	87.31	16.66	46	8840	19210	63460926
Incorrect route of product administration	82.26	16.66	50	8836	27402	63452734
Procedural pain	79.70	16.66	45	8841	21524	63458612
Steroid withdrawal syndrome	59.06	16.66	14	8872	531	63479605
Dermatitis atopic	49.16	16.66	25	8861	9699	63470437
Vaginal flatulence	48.45	16.66	18	8868	3275	63476861
Erythema	41.52	16.66	82	8804	175669	63304467
Psoriatic arthropathy	41.01	16.66	57	8829	91463	63388673
Proctitis	39.71	16.66	18	8868	5423	63474713
Dyspepsia	39.02	16.66	59	8827	102137	63377999
Female genital tract fistula	36.95	16.66	19	8867	7540	63472596
Therapeutic product effect incomplete	35.31	16.66	63	8823	124993	63355143
Pruritus	33.65	16.66	119	8767	361334	63118802
Radiculopathy	31.89	16.66	18	8868	8593	63471543
Oral candidiasis	31.76	16.66	26	8860	22772	63457364
Vaginal discharge	30.78	16.66	18	8868	9180	63470956
Portal vein cavernous transformation	29.09	16.66	6	8880	118	63480018
Colitis ulcerative	28.72	16.66	26	8860	26065	63454071
Nail psoriasis	28.02	16.66	8	8878	633	63479503
Dry skin	26.33	16.66	36	8850	56851	63423285
Lichenification	25.95	16.66	7	8879	449	63479687
Guttate psoriasis	25.90	16.66	7	8879	452	63479684
Eczema	25.81	16.66	27	8859	32264	63447872
Skin exfoliation	25.81	16.66	31	8855	43071	63437065
Theft	25.40	16.66	5	8881	77	63480059
Rectal haemorrhage	24.17	16.66	32	8854	48998	63431138
Central obesity	22.94	16.66	8	8878	1213	63478923
Skin fissures	22.51	16.66	16	8870	11372	63468764
Bacterial vulvovaginitis	22.10	16.66	7	8879	789	63479347
Toxic neuropathy	21.70	16.66	6	8880	422	63479714
Bacillus infection	21.62	16.66	7	8879	846	63479290
Frequent bowel movements	21.60	16.66	21	8865	23001	63457135
Arthropathy	20.49	16.66	4	8882	234788	63245348
Weight decreased	19.87	16.66	84	8802	276714	63203422
Cellulitis	19.03	16.66	38	8848	81920	63398216
Rheumatoid arthritis	18.90	16.66	6	8880	253813	63226323
Post-traumatic neck syndrome	18.82	16.66	8	8878	2066	63478070
Tachycardia paroxysmal	18.81	16.66	5	8881	303	63479833
Death	18.72	16.66	15	8871	374366	63105770
Lung opacity	18.54	16.66	9	8877	3159	63476977
Libido increased	18.50	16.66	7	8879	1338	63478798
Cutaneous T-cell lymphoma	18.33	16.66	7	8879	1373	63478763
Hepatic function abnormal	17.93	16.66	24	8862	37118	63443018
Skin atrophy	17.48	16.66	10	8876	4896	63475240
Subretinal haematoma	17.39	16.66	3	8883	21	63480115
Weaning failure	17.38	16.66	5	8881	406	63479730
Total bile acids increased	17.21	16.66	4	8882	139	63479997
Skin plaque	17.16	16.66	12	8874	8308	63471828
Soft tissue injury	17.11	16.66	7	8879	1645	63478491
Refractory anaemia with an excess of blasts	16.97	16.66	5	8881	442	63479694
Intraocular haematoma	16.72	16.66	3	8883	27	63480109

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug eruption	319.92	17.66	130	7341	19768	34929692
Hepatic function abnormal	242.15	17.66	138	7333	44225	34905235
Stomatitis	210.05	17.66	124	7347	42390	34907070
Hypersensitivity	182.86	17.66	130	7341	60905	34888555
Urticaria	178.03	17.66	129	7342	62248	34887212
Psoriasis	165.36	17.66	103	7368	38709	34910751
Epistaxis	158.32	17.66	117	7354	58134	34891326
Muscle spasms	146.50	17.66	124	7347	74877	34874583
Pain in extremity	140.29	17.66	153	7318	126360	34823100
Drug ineffective	69.47	17.66	234	7237	456517	34492943
Appendicolith	52.88	17.66	29	7442	8572	34940888
Blood phosphorus increased	50.16	17.66	27	7444	7694	34941766
Pneumonia	44.04	17.66	173	7298	362454	34587006
Appendicitis	42.96	17.66	31	7440	14776	34934684
Myasthenia gravis	38.84	17.66	22	7449	6918	34942542
Blood uric acid increased	37.05	17.66	24	7447	9600	34939860
Pulmonary vasculitis	33.72	17.66	10	7461	589	34948871
Pruritus	32.07	17.66	84	7387	141897	34807563
Polydipsia	32.07	17.66	16	7455	3899	34945561
Toxicity to various agents	31.95	17.66	3	7468	200359	34749101
Cardiogenic shock	30.75	17.66	33	7438	26585	34922875
Incorrect route of product administration	29.81	17.66	25	7446	14820	34934640
Erythrodermic psoriasis	29.63	17.66	10	7461	897	34948563
Neuritis	29.35	17.66	10	7461	924	34948536
Psoriatic arthropathy	29.18	17.66	28	7443	19770	34929690
Blood cholesterol increased	26.47	17.66	27	7444	20516	34928944
Respiratory symptom	26.30	17.66	11	7460	1786	34947674
Ventricular fibrillation	25.71	17.66	28	7443	22926	34926534
Stress	25.61	17.66	32	7439	30315	34919145
Therapeutic product effect incomplete	21.93	17.66	39	7432	50502	34898958
Skin exfoliation	21.68	17.66	28	7443	27404	34922056
Adrenal insufficiency	19.08	17.66	19	7452	14028	34935432
Drug interaction	18.31	17.66	13	7458	225933	34723527
African trypanosomiasis	18.20	17.66	3	7468	9	34949451
Dry mouth	18.15	17.66	27	7444	30138	34919322
Ascites	17.76	17.66	34	7437	46537	34902923

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Psoriasis	349.66	14.11	213	14474	89374	79640327
Drug eruption	270.66	14.11	141	14546	43794	79685907
Hepatic function abnormal	240.33	14.11	156	14531	72951	79656750
Urticaria	117.31	14.11	157	14530	185044	79544657
Stomatitis	116.08	14.11	139	14548	146618	79583083
Epistaxis	110.93	14.11	119	14568	111396	79618305
Incorrect route of product administration	103.66	14.11	70	14617	34859	79694842
Pain in extremity	95.02	14.11	208	14479	364330	79365371
Muscle spasms	89.68	14.11	134	14553	174596	79555105
Macular degeneration	83.35	14.11	41	14646	11255	79718446
Chronic sinusitis	80.68	14.11	42	14645	12984	79716717
Product use in unapproved indication	73.42	14.11	150	14537	250209	79479492
Paraesthesia oral	72.90	14.11	46	14641	20425	79709276
Drug ineffective	70.55	14.11	387	14300	1080526	78649175
Procedural pain	63.13	14.11	44	14643	23040	79706661
Appendicolith	57.08	14.11	29	14658	8522	79721179
Hypersensitivity	51.29	14.11	134	14553	262105	79467596
Vaginal flatulence	47.94	14.11	18	14669	2557	79727144
Psoriatic arthropathy	47.57	14.11	65	14622	77934	79651767
Blood phosphorus increased	46.50	14.11	27	14660	10320	79719381
Therapeutic product effect incomplete	44.00	14.11	87	14600	141558	79588143
Toxicity to various agents	43.38	14.11	12	14675	421528	79308173
Appendicitis	41.93	14.11	33	14654	20761	79708940
Pruritus	39.99	14.11	161	14526	394487	79335214
Erythrodermic psoriasis	39.07	14.11	14	14673	1744	79727957
Erythema	37.55	14.11	108	14579	223182	79506519
Female genital tract fistula	36.24	14.11	19	14668	5956	79723745
Myasthenia gravis	36.10	14.11	23	14664	10376	79719325
Drug interaction	34.03	14.11	17	14670	415166	79314535
Blood uric acid increased	33.14	14.11	24	14663	13336	79716365
Pulmonary vasculitis	32.82	14.11	10	14677	751	79728950
Proctitis	32.17	14.11	18	14669	6414	79723287
Dermatitis atopic	31.86	14.11	21	14666	10035	79719666
Vaginal discharge	29.69	14.11	18	14669	7445	79722256
Skin fissures	29.09	14.11	22	14665	13051	79716650
Steroid withdrawal syndrome	29.08	14.11	9	14678	712	79728989
Neuritis	28.11	14.11	11	14676	1747	79727954
Portal vein cavernous transformation	27.17	14.11	6	14681	124	79729577
Radiculopathy	26.92	14.11	18	14669	8806	79720895
Oral candidiasis	26.61	14.11	30	14657	29598	79700103
Polydipsia	26.45	14.11	16	14671	6589	79723112
Skin exfoliation	26.43	14.11	41	14646	55059	79674642
Eczema	26.38	14.11	35	14652	40783	79688918
Dyspepsia	25.94	14.11	60	14627	108627	79621074
Cellulitis	25.80	14.11	60	14627	109000	79620701
Pneumonia	24.97	14.11	207	14480	660039	79069662
Guttate psoriasis	23.88	14.11	7	14680	460	79729241
Dry skin	23.85	14.11	44	14643	67951	79661750
Rheumatoid arthritis	23.24	14.11	5	14682	208465	79521236
Cardiogenic shock	22.68	14.11	33	14654	41881	79687820
Adrenal insufficiency	22.50	14.11	27	14660	28460	79701241
Arthropathy	22.49	14.11	3	14684	177108	79552593
Hypotension	22.37	14.11	29	14658	440288	79289413
Bacterial vulvovaginitis	22.10	14.11	7	14680	598	79729103
Pemphigoid	22.01	14.11	20	14667	15295	79714406
Nail psoriasis	21.65	14.11	7	14680	638	79729063
Ventricular fibrillation	21.60	14.11	28	14659	31898	79697803
Skin lesion	21.28	14.11	32	14655	41812	79687889
Central obesity	21.24	14.11	9	14678	1752	79727949
Skin atrophy	20.73	14.11	13	14674	5705	79723996
Male genital atrophy	20.72	14.11	3	14684	3	79729698
Colitis ulcerative	19.75	14.11	28	14659	34714	79694987
Skin plaque	19.43	14.11	16	14671	10729	79718972
Stress	19.04	14.11	44	14643	79568	79650133
African trypanosomiasis	18.40	14.11	3	14684	10	79729691
Seizure	18.26	14.11	6	14681	188828	79540873
Bacillus infection	17.67	14.11	7	14680	1148	79728553
Respiratory symptom	17.64	14.11	11	14676	4780	79724921
Cell marker increased	17.60	14.11	6	14681	645	79729056
Spontaneous ejaculation	17.60	14.11	3	14684	14	79729687
Iron deficiency	17.48	14.11	15	14672	10639	79719062
Toxic skin eruption	17.39	14.11	21	14666	22272	79707429
Inappropriate schedule of product administration	17.24	14.11	59	14628	133569	79596132
Contraindicated product administered	17.11	14.11	4	14683	157534	79572167
Frequent bowel movements	17.07	14.11	24	14663	29515	79700186
Hypothalamic pituitary adrenal axis suppression	17.04	14.11	5	14682	330	79729371
Post-traumatic neck syndrome	16.65	14.11	8	14679	2086	79727615
Tachycardia paroxysmal	16.15	14.11	5	14682	396	79729305
Asthenia	16.06	14.11	45	14642	511644	79218057
Splenic granuloma	15.35	14.11	3	14684	33	79729668
Erysipelas	15.26	14.11	14	14673	10836	79718865
Toxic neuropathy	15.21	14.11	6	14681	974	79728727
Cushing's syndrome	15.12	14.11	6	14681	989	79728712
Skin irritation	14.84	14.11	14	14673	11226	79718475
Soft tissue injury	14.75	14.11	7	14680	1774	79727927
Cutaneous T-cell lymphoma	14.72	14.11	8	14679	2695	79727006
Malaise	14.60	14.11	146	14541	489723	79239978
Shared psychotic disorder	14.55	14.11	3	14684	44	79729657
Lung opacity	14.46	14.11	10	14677	5164	79724537
Erythema multiforme	14.38	14.11	17	14670	17634	79712067
Synovitis	14.21	14.11	5	14682	150729	79578972
Death	14.21	14.11	55	14632	566459	79163242

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
FDA MoA	N0000175450	Corticosteroid Hormone Receptor Agonists
FDA EPC	N0000175576	Corticosteroid
MeSH PA	D000893	Anti-Inflammatory Agents
CHEBI has role	CHEBI:35472	anti-inflammatory drugs
CHEBI has role	CHEBI:35705	immunosuppressive agents
CHEBI has role	CHEBI:65023	anti-asthmatic agents
MeSH PA	D018927	Anti-Asthmatic Agents
MeSH PA	D005938	Glucocorticoids
MeSH PA	D006728	Hormones
MeSH PA	D019141	Respiratory System Agents

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Tinea pedis	indication	6020002	DOID:12403
Atopic dermatitis	indication	24079001	DOID:3310
Contact dermatitis	indication	40275004	DOID:2773
Seborrheic dermatitis	indication	50563003	DOID:8741
Lichen simplex chronicus	indication	53891004
Granuloma annulare	indication	65508009	DOID:3777
Tinea corporis	indication	84849002
Pruritus ani	indication	90446007
Discoid lupus erythematosus	indication	200938002
Plaque psoriasis	indication	200965009
Scalp psoriasis	indication	238608008
Pruritus of genital organs	indication	267802000
Eruption of skin	indication	271807003	DOID:0050486
Tinea cruris	indication	399029005
Primary cutaneous T-cell lymphoma	indication	400122007
Psoriasis	off-label use	9014002	DOID:8893
Congenital ichthyosis of skin	contraindication	13059002
Hypervitaminosis D	contraindication	27712000	DOID:9971
Guttate psoriasis	contraindication	37042000
Hypercalcemia	contraindication	66931009	DOID:12678
Disorder of calcium metabolism	contraindication	71638002	DOID:10575
Hypercalciuria	contraindication	71938000
Pustular psoriasis	contraindication	200973000
Telangiectasia disorder	contraindication	247479008
Adrenal cortical hypofunction	contraindication	386584007	DOID:10493
Atrophoderma	contraindication	399979006
Peripheral vascular disease	contraindication	400047006

🐶 Veterinary Drug Use

Species	Use	Relation
Cats	Pruritus associated with dermatoses	Indication
Dogs	Pruritus associated with dermatoses	Indication
Horses	Inflammatory joint conditions	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Betasone Aqueous Suspension	Intervet Inc.	2

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.48	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 0.05% BASE/SPRAY	SERNIVO	PRIMUS PHARMS	N208079	Feb. 5, 2016	RX	SPRAY	TOPICAL	10179137	Aug. 31, 2030	TREATMENT OF PLAQUE PSORIASIS
EQ 0.05% BASE/SPRAY	SERNIVO	PRIMUS PHARMS	N208079	Feb. 5, 2016	RX	SPRAY	TOPICAL	9364485	Aug. 31, 2030	TREATMENT OF PLAQUE PSORIASIS
EQ 0.05% BASE/SPRAY	SERNIVO	PRIMUS PHARMS	N208079	Feb. 5, 2016	RX	SPRAY	TOPICAL	9433630	Aug. 31, 2030	TREATMENT OF PLAQUE PSORIASIS
EQ 0.05% BASE/SPRAY	SERNIVO	PRIMUS PHARMS	N208079	Feb. 5, 2016	RX	SPRAY	TOPICAL	9439911	Aug. 31, 2030	TREATMENT OF PLAQUE PSORIASIS
EQ 0.05% BASE/SPRAY	SERNIVO	PRIMUS PHARMS	N208079	Feb. 5, 2016	RX	SPRAY	TOPICAL	9655907	Aug. 31, 2030	TREATMENT OF PLAQUE PSORIASIS
EQ 0.05% BASE/SPRAY	SERNIVO	PRIMUS PHARMS	N208079	Feb. 5, 2016	RX	SPRAY	TOPICAL	9775851	Aug. 31, 2030	TREATMENT OF PLAQUE PSORIASIS
EQ 0.05% BASE/SPRAY	SERNIVO	PRIMUS PHARMS	N208079	Feb. 5, 2016	RX	SPRAY	TOPICAL	9877974	Aug. 31, 2030	TREATMENT OF PLAQUE PSORIASIS
0.064%;0.005%	ENSTILAR	LEO PHARMA AS	N207589	Oct. 16, 2015	RX	AEROSOL, FOAM	TOPICAL	10660908	June 10, 2031	TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 12 YEARS AND OLDER
0.064%;0.005%	ENSTILAR	LEO PHARMA AS	N207589	Oct. 16, 2015	RX	AEROSOL, FOAM	TOPICAL	10688108	June 10, 2031	TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 12 YEARS AND OLDER
0.064%;0.005%	ENSTILAR	LEO PHARMA AS	N207589	Oct. 16, 2015	RX	AEROSOL, FOAM	TOPICAL	9119781	June 10, 2031	PLAQUE PSORIASIS
0.064%;0.005%	ENSTILAR	LEO PHARMA AS	N207589	Oct. 16, 2015	RX	AEROSOL, FOAM	TOPICAL	9119781	June 10, 2031	TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 12 YEARS AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
0.064%;0.005%	TACLONEX	LEO PHARMA AS	N022185	May 9, 2008	RX	SUSPENSION	TOPICAL	Jan. 25, 2023	PEDIATRIC EXCLUSIVITY
0.064%;0.005%	ENSTILAR	LEO PHARMA AS	N207589	Oct. 16, 2015	RX	AEROSOL, FOAM	TOPICAL	Jan. 30, 2023	PEDIATRIC EXCLUSIVITY
0.064%;0.005%	WYNZORA	MC2	N213422	July 20, 2020	RX	CREAM	TOPICAL	July 20, 2023	NEW DOSAGE FORM

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST				CHEMBL	CHEMBL
Glucocorticoid receptor	Transcription factor		GCR_RAT		IC50	8.28		CHEMBL

External reference:

ID	Source
4018642	VUID
N0000179052	NUI
D01637	KEGG_DRUG
1514	RXNORM
C0053523	UMLSCUI
CHEBI:3077	CHEBI
CHEMBL1200384	ChEMBL_ID
C011175	MESH_SUPPLEMENTAL_RECORD_UI
826Y60901U	UNII
21800	PUBCHEM_CID
DB00443	DRUGBANK_ID
10006	MMSL
129	MMSL
31630	MMSL
3190	MMSL
4270	MMSL
4273	MMSL
d00628	MMSL
116571008	SNOMEDCT_US
29896003	SNOMEDCT_US
88736007	SNOMEDCT_US
C0005308	UMLSCUI
4018642	VANDF
4018644	VANDF
1045	INN_ID
9782	PUBCHEM_CID
D001623	MESH_DESCRIPTOR_UI
002168	NDDF
002171	NDDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Lotrisone	HUMAN PRESCRIPTION DRUG LABEL	2	0085-0924	CREAM	0.50 mg	TOPICAL	NDA	26 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0055	CREAM	0.50 mg	TOPICAL	NDA	18 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0056	OINTMENT	0.50 mg	TOPICAL	NDA	18 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0057	LOTION	0.50 mg	TOPICAL	ANDA	18 sections
Clotrimazole and Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	2	0168-0258	CREAM	0.50 mg	TOPICAL	ANDA	27 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0265	CREAM, AUGMENTED	0.50 mg	TOPICAL	ANDA	27 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0267	LOTION, AUGMENTED	0.50 mg	TOPICAL	ANDA	27 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0267	LOTION, AUGMENTED	0.50 mg	TOPICAL	ANDA	27 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0168-0268	OINTMENT, AUGMENTED	0.50 mg	TOPICAL	ANDA	27 sections
Clotrimazole and Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	2	0168-0370	LOTION	0.50 mg	TOPICAL	ANDA	20 sections
Clotrimazole and Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	2	0472-0379	CREAM	0.50 mg	TOPICAL	ANDA	24 sections
Clotrimazole and Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	2	0472-0379	CREAM	0.50 mg	TOPICAL	ANDA	24 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0472-0380	CREAM	0.50 mg	TOPICAL	ANDA	10 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0472-0381	OINTMENT	0.50 mg	TOPICAL	ANDA	10 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0472-0381	OINTMENT	0.50 mg	TOPICAL	ANDA	10 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0472-0382	OINTMENT, AUGMENTED	0.50 mg	TOPICAL	ANDA	26 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0472-0382	OINTMENT, AUGMENTED	0.50 mg	TOPICAL	ANDA	26 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0659	CREAM	0.50 mg	TOPICAL	ANDA	10 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0659	CREAM	0.50 mg	TOPICAL	ANDA	10 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0728	LOTION	0.50 mg	TOPICAL	ANDA	11 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0728	LOTION	0.50 mg	TOPICAL	ANDA	11 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0759	CREAM	0.50 mg	TOPICAL	ANDA	11 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0759	CREAM	0.50 mg	TOPICAL	ANDA	11 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0807	LOTION	0.50 mg	TOPICAL	ANDA	11 sections
Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	1	0713-0807	LOTION	0.50 mg	TOPICAL	ANDA	11 sections
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	HUMAN PRESCRIPTION DRUG LABEL	2	0781-7165	OINTMENT	0.50 mg	TOPICAL	ANDA	22 sections
BETAMETHASONE DIPROPIONATE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-032	CREAM	0.64 mg	TOPICAL	ANDA	18 sections
BETAMETHASONE CLOTRIMAZOLE	HUMAN PRESCRIPTION DRUG LABEL	2	16590-033	CREAM	0.64 mg	TOPICAL	ANDA	12 sections
Clotrimazole and Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	2	16714-496	CREAM	0.64 mg	TOPICAL	ANDA	28 sections
Clotrimazole and Betamethasone Dipropionate	HUMAN PRESCRIPTION DRUG LABEL	2	16714-496	CREAM	0.64 mg	TOPICAL	ANDA	28 sections