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

Stem definition	Drug id	CAS RN
antimycobacterials, diaminodiphenylsulfone derivatives	782	80-08-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: dapsone diaphenylsulfon diaphenylsulfone sulphadione dapson	A sulfone active against a wide range of bacteria but mainly employed for its actions against MYCOBACTERIUM LEPRAE. Its mechanism of action is probably similar to that of the SULFONAMIDES which involves inhibition of folic acid synthesis in susceptible organisms. It is also used with PYRIMETHAMINE in the treatment of malaria. (From Martindale, The Extra Pharmacopoeia, 30th ed, p157-8) Molecular weight: 248.30 Formula: C12H12N2O2S CLOGP: 0.89 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 86.18 ALOGS: -2.94 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

dapsone
diaphenylsulfon
diaphenylsulfone
sulphadione
dapson

A sulfone active against a wide range of bacteria but mainly employed for its actions against MYCOBACTERIUM LEPRAE. Its mechanism of action is probably similar to that of the SULFONAMIDES which involves inhibition of folic acid synthesis in susceptible organisms. It is also used with PYRIMETHAMINE in the treatment of malaria. (From Martindale, The Extra Pharmacopoeia, 30th ed, p157-8)

Molecular weight: 248.30
Formula: C12H12N2O2S
CLOGP: 0.89
LIPINSKI: 0
HAC: 4
HDO: 2
TPSA: 86.18
ALOGS: -2.94
ROTB: 2

Status: OFP

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

Drug dosage:

Dose	Unit	Route
50	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.20 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	15 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	20.14 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	93 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.83 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.48 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.25 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	22 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
July 3, 1979	FDA	JACOBUS

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
Methaemoglobinaemia	586.24	16.06	119	7830	1923	50595252
Drug reaction with eosinophilia and systemic symptoms	293.55	16.06	124	7825	28300	50568875
Haemolytic anaemia	131.85	16.06	51	7898	9241	50587934
Blood methaemoglobin present	51.38	16.06	9	7940	61	50597114
Type 2 lepra reaction	50.27	16.06	8	7941	27	50597148
Off label use	46.99	16.06	172	7777	474254	50122921
Skin odour abnormal	39.62	16.06	13	7936	1459	50595716
Drug ineffective	35.31	16.06	234	7715	819099	49778076
Myopathy	34.14	16.06	20	7929	9119	50588056
Hepatitis fulminant	33.66	16.06	14	7935	3054	50594121
Haemolysis	33.09	16.06	17	7932	5999	50591176
Idiopathic pneumonia syndrome	32.13	16.06	8	7941	332	50596843
Sepsis	29.82	16.06	65	7884	132860	50464315
Treatment failure	29.40	16.06	66	7883	137571	50459604
Type IIb hyperlipidaemia	29.07	16.06	5	7944	30	50597145
Wound secretion	27.60	16.06	13	7936	3804	50593371
Drug-induced liver injury	26.35	16.06	27	7922	28068	50569107
Skin lesion	23.83	16.06	25	7924	26702	50570473
Pseudomonas infection	23.57	16.06	16	7933	9414	50587761
Thyroid tuberculosis	23.55	16.06	4	7945	22	50597153
Product use in unapproved indication	23.02	16.06	54	7895	115765	50481410
Klebsiella infection	22.38	16.06	14	7935	7180	50589995
Skin exfoliation	22.37	16.06	27	7922	33585	50563590
Congenital hydrocephalus	22.09	16.06	5	7944	137	50597038
Eosinophilic myocarditis	21.96	16.06	6	7943	359	50596816
Leukopenia	21.14	16.06	38	7911	67490	50529685
Skin hyperpigmentation	20.91	16.06	12	7937	5264	50591911
Cyanosis	20.78	16.06	18	7931	15166	50582009
Dermatitis herpetiformis	19.67	16.06	3	7946	7	50597168
Marrow hyperplasia	19.25	16.06	6	7943	571	50596604
Drug ineffective for unapproved indication	19.14	16.06	20	7929	21261	50575914
Oxygen saturation decreased	18.95	16.06	38	7911	73210	50523965
Cushingoid	18.36	16.06	12	7937	6633	50590542
Abdominal discomfort	17.90	16.06	7	7942	231634	50365541
Pyrexia	17.69	16.06	111	7838	380092	50217083
Rash erythematous	16.97	16.06	24	7925	34828	50562347
Bronchopulmonary aspergillosis	16.91	16.06	12	7937	7580	50589595
Choriomeningitis lymphocytic	16.58	16.06	3	7946	25	50597150
Joint swelling	16.50	16.06	9	7940	245277	50351898
Methylobacterium infection	16.37	16.06	3	7946	27	50597148
Scar	16.15	16.06	14	7935	11804	50585371
Calciphylaxis	16.10	16.06	8	7941	2630	50594545

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
Methaemoglobinaemia	258.58	16.61	72	8130	2599	29563726
Drug reaction with eosinophilia and systemic symptoms	174.21	16.61	104	8098	27888	29538437
Type 2 lepra reaction	148.86	16.61	28	8174	155	29566170
Haemolytic anaemia	100.34	16.61	50	8152	9369	29556956
Vanishing bile duct syndrome	91.02	16.61	23	8179	565	29565760
Type 1 lepra reaction	71.86	16.61	12	8190	28	29566297
Brain abscess	50.12	16.61	21	8181	2634	29563691
Mycobacterium avium complex infection	49.83	16.61	20	8182	2249	29564076
Drug-induced liver injury	47.74	16.61	43	8159	21612	29544713
Pleocytosis	46.68	16.61	13	8189	468	29565857
Pyrexia	46.06	16.61	179	8023	287443	29278882
Nocardiosis	36.76	16.61	18	8184	3242	29563083
Haemolysis	33.50	16.61	22	8180	6934	29559391
Blood methaemoglobin present	33.50	16.61	6	8196	24	29566301
HIV associated nephropathy	33.30	16.61	9	8193	289	29566036
Aeromonas infection	29.84	16.61	8	8194	249	29566076
Toxoplasmosis	28.12	16.61	11	8191	1156	29565169
Pancytopenia	26.57	16.61	66	8136	83102	29483223
Fluid imbalance	25.60	16.61	7	8195	235	29566090
Papillary cystadenoma lymphomatosum	25.44	16.61	5	8197	36	29566289
Photophobia	24.20	16.61	17	8185	5978	29560347
Mucormycosis	24.08	16.61	16	8186	5142	29561183
Induration	23.76	16.61	9	8193	867	29565458
Hypoxia	23.60	16.61	45	8157	47334	29518991
Mycobacterium abscessus infection	21.26	16.61	7	8195	447	29565878
Disseminated cryptococcosis	21.18	16.61	9	8193	1169	29565156
Pneumonia cryptococcal	21.14	16.61	8	8194	768	29565557
Epstein-Barr virus infection	20.47	16.61	16	8186	6613	29559712
Cushingoid	20.36	16.61	11	8191	2427	29563898
Autoinflammatory disease	18.08	16.61	4	8198	54	29566271
Granuloma	17.52	16.61	10	8192	2454	29563871
Disseminated mycobacterium avium complex infection	17.45	16.61	4	8198	64	29566261
Graft versus host disease	17.15	16.61	17	8185	9611	29556714
Necrotising fasciitis	17.08	16.61	11	8191	3354	29562971

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
Methaemoglobinaemia	711.43	13.65	169	13688	4179	64480696
Drug reaction with eosinophilia and systemic symptoms	463.47	13.65	228	13629	53989	64430886
Haemolytic anaemia	223.76	13.65	95	13762	15958	64468917
Type 2 lepra reaction	184.72	13.65	33	13824	177	64484698
Type 1 lepra reaction	86.72	13.65	14	13843	35	64484840
Vanishing bile duct syndrome	83.61	13.65	24	13833	1253	64483622
Blood methaemoglobin present	81.97	13.65	15	13842	94	64484781
Drug-induced liver injury	76.88	13.65	71	13786	47572	64437303
Haemolysis	56.29	13.65	33	13824	11006	64473869
Pyrexia	54.09	13.65	250	13607	558394	63926481
Nocardiosis	49.61	13.65	23	13834	4744	64480131
Brain abscess	46.10	13.65	21	13836	4160	64480715
Treatment failure	42.70	13.65	84	13773	116732	64368143
Pseudomonas infection	39.70	13.65	32	13825	17851	64467024
Pancytopenia	39.63	13.65	92	13765	143217	64341658
Drug ineffective	39.31	13.65	311	13546	839936	63644939
Pleocytosis	39.26	13.65	13	13844	1094	64483781
Cushingoid	36.86	13.65	22	13835	7581	64477294
HIV associated nephropathy	35.49	13.65	9	13848	292	64484583
Hypoxia	34.17	13.65	65	13792	88084	64396791
Product use in unapproved indication	32.11	13.65	97	13760	176521	64308354
Mycobacterium avium complex infection	31.88	13.65	16	13841	3924	64480951
Aeromonas infection	29.62	13.65	8	13849	333	64484542
Skin exfoliation	29.48	13.65	42	13815	44843	64440032
Drug ineffective for unapproved indication	28.00	13.65	34	13823	31099	64453776
Type IIb hyperlipidaemia	27.51	13.65	5	13852	30	64484845
Myopathy	25.92	13.65	25	13832	17655	64467220
Skin odour abnormal	25.83	13.65	11	13846	1856	64483019
Off label use	25.63	13.65	227	13630	632579	63852296
Sepsis	25.12	13.65	107	13750	230234	64254641
Mucormycosis	25.01	13.65	17	13840	7324	64477551
Epstein-Barr virus infection	24.91	13.65	21	13836	12467	64472408
Skin lesion	23.75	13.65	34	13823	36448	64448427
Induration	23.67	13.65	10	13847	1654	64483221
Fluid imbalance	23.32	13.65	7	13850	427	64484448
Pneumocystis jirovecii pneumonia	22.95	13.65	29	13828	27605	64457270
Leukopenia	22.69	13.65	60	13797	101182	64383693
Anaemia	22.08	13.65	148	13709	378532	64106343
Cutaneous lupus erythematosus	22.02	13.65	11	13846	2671	64482204
Thyroid tuberculosis	22.01	13.65	4	13853	24	64484851
Papillary cystadenoma lymphomatosum	21.94	13.65	5	13852	102	64484773
Idiopathic pneumonia syndrome	21.70	13.65	7	13850	542	64484333
Leukocytosis	21.45	13.65	33	13824	37707	64447168
Therapy non-responder	21.23	13.65	45	13812	65854	64419021
Antineutrophil cytoplasmic antibody positive	21.06	13.65	8	13849	1004	64483871
Disseminated cryptococcosis	20.91	13.65	9	13848	1558	64483317
Hepatitis fulminant	20.12	13.65	14	13843	6260	64478615
Toxoplasmosis	20.00	13.65	10	13847	2434	64482441
Rash maculo-papular	19.87	13.65	36	13821	46990	64437885
Staphylococcal bacteraemia	19.80	13.65	17	13840	10338	64474537
Necrotising fasciitis	19.74	13.65	13	13844	5313	64479562
Cyanosis	19.60	13.65	24	13833	22131	64462744
Joint swelling	19.52	13.65	11	13846	215371	64269504
Pneumonia cryptococcal	19.49	13.65	8	13849	1231	64483644
Jaundice	19.07	13.65	36	13821	48476	64436399
Mucocutaneous leishmaniasis	19.03	13.65	6	13851	432	64484443
Eosinophilic myocarditis	18.69	13.65	7	13850	845	64484030
Respiratory failure	18.43	13.65	76	13781	161107	64323768
Pneumonia	18.30	13.65	192	13665	559384	63925491
Pain in extremity	18.24	13.65	23	13834	303062	64181813
Wound secretion	17.54	13.65	12	13845	5220	64479655
Mycobacterium abscessus infection	17.51	13.65	7	13850	1007	64483868
Graft versus host disease	17.42	13.65	18	13839	13795	64471080
Pain	17.32	13.65	61	13796	553450	63931425
Skin hyperpigmentation	17.31	13.65	13	13844	6538	64478337
Disseminated mycobacterium avium complex infection	16.66	13.65	4	13853	103	64484772
Plasma cell myeloma	16.65	13.65	33	13824	46042	64438833
Arthropathy	16.53	13.65	3	13854	120964	64363911
Tuberculoid leprosy	16.48	13.65	4	13853	108	64484767
Klebsiella infection	16.20	13.65	17	13840	13264	64471611
Application site discolouration	16.11	13.65	6	13851	714	64484161
Linear IgA disease	16.03	13.65	9	13848	2765	64482110
Bronchopulmonary aspergillosis	15.80	13.65	20	13837	19065	64465810
Infection reactivation	15.71	13.65	8	13849	2022	64482853
Clostridium difficile infection	15.68	13.65	28	13829	36135	64448740
Staphylococcal infection	15.62	13.65	34	13823	50644	64434231
Methylobacterium infection	15.44	13.65	3	13854	27	64484848
Thrombocytopenia	15.20	13.65	91	13766	223710	64261165
Arthralgia	15.02	13.65	47	13810	442213	64042662
Vascular cognitive impairment	14.89	13.65	3	13854	33	64484842
Calciphylaxis	14.55	13.65	9	13848	3303	64481572
Application site dryness	14.51	13.65	4	13853	180	64484695
CD4 lymphocytes decreased	14.34	13.65	8	13849	2427	64482448
Photophobia	14.13	13.65	18	13839	17275	64467600
Rheumatoid arthritis	14.02	13.65	9	13848	164285	64320590
Cryopyrin associated periodic syndrome	13.73	13.65	3	13854	50	64484825
Renal failure	13.72	13.65	76	13781	181612	64303263

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	D10AX05	DERMATOLOGICALS ANTI-ACNE PREPARATIONS ANTI-ACNE PREPARATIONS FOR TOPICAL USE Other anti-acne preparations for topical use
ATC	J04BA02	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF LEPRA Drugs for treatment of lepra
FDA CS	M0020791	Sulfones
CHEBI has role	CHEBI:35441	antiinfective agents
CHEBI has role	CHEBI:35472	anti-inflammatory drugs
CHEBI has role	CHEBI:35816	leprostatic drugs
CHEBI has role	CHEBI:38068	antimalarials
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000962	Antimalarials
MeSH PA	D000977	Antiparasitic Agents
MeSH PA	D000981	Antiprotozoal Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D005493	Folic Acid Antagonists
MeSH PA	D007917	Leprostatic Agents
FDA EPC	N0000175881	Sulfone

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

Disease	Relation	SNOMED_ID	DOID
Leprosy	indication	81004002	DOID:1024
Acne vulgaris	indication	88616000
Dermatitis herpetiformis	indication	111196000	DOID:8505
Subcorneal pustular dermatosis	off-label use	25147002	DOID:8508
Benign mucous membrane pemphigoid	off-label use	34250006	DOID:11656
Systemic lupus erythematosus	off-label use	55464009	DOID:9074
Granuloma annulare	off-label use	65508009	DOID:3777
Pyoderma gangrenosum	off-label use	74578003	DOID:8553
Pemphigoid	off-label use	86142006
Actinomycotic mycetoma	off-label use	187089001
Toxoplasmosis	off-label use	187192000	DOID:9965
Pneumocystosis jiroveci pneumonia	off-label use	415125002	DOID:11339
Pneumocystis Carinii Pneumonia Prevention	off-label use
Anemia due to enzyme deficiency	contraindication	111577008
Deficiency of glucose-6-phosphate dehydrogenase	contraindication	124134002	DOID:2862
Deficiency of cytochrome-b>5< reductase	contraindication	124184009
Disease of liver	contraindication	235856003	DOID:409
Anemia	contraindication	271737000	DOID:2355

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.34	Basic
pKa2	1.73	Basic

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
7.5%	ACZONE	ALMIRALL	N207154	Feb. 24, 2016	RX	GEL	TOPICAL	9517219	Nov. 18, 2033	TOPICAL TREATMENT OF ACNE VULGARIS

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
7.5%	ACZONE	ALMIRALL	N207154	Feb. 24, 2016	RX	GEL	TOPICAL	Sept. 10, 2022	NEW PATIENT POPULATION

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
5-hydroxytryptamine receptor 6	GPCR	P50406	5HT6R_HUMAN		Ki	6.74	CHEMBL
Myeloperoxidase	Enzyme	P05164	PERM_HUMAN		IC50	6.38	CHEMBL
Glucose-6-phosphate 1-dehydrogenase	Enzyme	P11413	G6PD_HUMAN				WOMBAT-PK
Cytochrome P450 3A4	Enzyme	P08684	CP3A4_HUMAN		Ki	4.57	WOMBAT-PK
Dihydropteroate synthase 1	Enzyme		DHPS1_MYCLE	INHIBITOR	IC50	5.90	WOMBAT-PK	CHEMBL
Dihydrofolate reductase	Enzyme		DYR_PNECA		IC50	5.82	CHEMBL
Dihydropteroate synthetase, putative	Unclassified		Q4Z710_PLABA		IC50	4.91	CHEMBL
6-hydroxymethyl-7,8-dihydropterin pyrophosphokinase	Unclassified		A0A113T0T6_PLABE		IC50	4.91	CHEMBL

External reference:

ID	Source
4019264	VUID
N0000147467	NUI
D00592	KEGG_DRUG
3108	RXNORM
4019264	VANDF
C0010980	UMLSCUI
CHEBI:4325	CHEBI
CHEMBL1043	ChEMBL_ID
DB00250	DRUGBANK_ID
D003622	MESH_DESCRIPTOR_UI
2955	PUBCHEM_CID
10934	IUPHAR_LIGAND_ID
1676	INN_ID
8W5C518302	UNII
4536	MMSL
682	MMSL
d00098	MMSL
003003	NDDF
17308007	SNOMEDCT_US
387096002	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ACZONE	HUMAN PRESCRIPTION DRUG LABEL	1	0023-3670	GEL	50 mg	TOPICAL	NDA	26 sections
ACZONE7.5	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5206	GEL	75 mg	TOPICAL	NDA	26 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	0378-4830	GEL	75 mg	TOPICAL	ANDA	25 sections
DAPSONE	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7018	TABLET	100 mg	ORAL	ANDA	11 sections
DAPSONE	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7019	TABLET	25 mg	ORAL	ANDA	11 sections
DAPSONE	HUMAN PRESCRIPTION DRUG LABEL	1	10135-654	TABLET	25 mg	ORAL	ANDA	19 sections
DAPSONE	HUMAN PRESCRIPTION DRUG LABEL	1	10135-655	TABLET	100 mg	ORAL	ANDA	19 sections
dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	13668-605	GEL	75 mg	TOPICAL	ANDA	23 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	13925-504	TABLET	25 mg	ORAL	ANDA	19 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	13925-505	TABLET	100 mg	ORAL	ANDA	19 sections
ACZONE	HUMAN PRESCRIPTION DRUG LABEL	1	16110-367	GEL	50 mg	TOPICAL	NDA	26 sections
Aczone	HUMAN PRESCRIPTION DRUG LABEL	1	16110-526	GEL	75 mg	TOPICAL	NDA	26 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	16714-956	GEL	50 mg	TOPICAL	ANDA	26 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	29033-036	TABLET	25 mg	ORAL	ANDA	18 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	29033-037	TABLET	100 mg	ORAL	ANDA	18 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	43353-222	TABLET	25 mg	ORAL	ANDA	21 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	43353-223	TABLET	100 mg	ORAL	ANDA	21 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	49938-101	TABLET	100 mg	ORAL	ANDA	18 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	49938-101	TABLET	100 mg	ORAL	ANDA	18 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	49938-102	TABLET	25 mg	ORAL	ANDA	18 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	49938-102	TABLET	25 mg	ORAL	ANDA	18 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	51672-1387	GEL	50 mg	TOPICAL	ANDA	26 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	51672-1388	GEL	75 mg	TOPICAL	ANDA	28 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	51672-1388	GEL	75 mg	TOPICAL	ANDA	28 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	51672-4197	TABLET	25 mg	ORAL	ANDA	20 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	51672-4198	TABLET	100 mg	ORAL	ANDA	20 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	51672-5307	GEL	75 mg	TOPICAL	NDA authorized generic	26 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	54868-2817	TABLET	25 mg	ORAL	ANDA	18 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	54868-3801	TABLET	100 mg	ORAL	ANDA	18 sections
Dapsone	HUMAN PRESCRIPTION DRUG LABEL	1	55695-005	TABLET	25 mg	ORAL	ANDA	18 sections