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	770.37	15.36	153	9621	2250	63476998
Drug reaction with eosinophilia and systemic symptoms	281.38	15.36	126	9648	33710	63445538
Haemolytic anaemia	149.87	15.36	57	9717	10068	63469180
Off label use	104.22	15.36	281	9493	674181	62805067
Drug ineffective	70.24	15.36	331	9443	1044434	62434814
Blood methaemoglobin present	57.79	15.36	10	9764	64	63479184
Type 2 lepra reaction	56.60	15.36	9	9765	31	63479217
Treatment failure	54.01	15.36	104	9670	198939	63280309
Haemolysis	52.36	15.36	24	9750	6744	63472504
Sepsis	49.08	15.36	86	9688	153037	63326211
Drug ineffective for unapproved indication	46.58	15.36	40	9734	34023	63445225
Skin odour abnormal	42.26	15.36	14	9760	1652	63477596
Product use in unapproved indication	38.45	15.36	85	9689	178995	63300253
Hydronephrosis	36.76	15.36	22	9752	10640	63468608
Cytomegalovirus infection	33.62	15.36	27	9747	20925	63458323
Myopathy	33.25	15.36	21	9753	11170	63468078
Hepatitis fulminant	32.29	15.36	14	9760	3450	63475798
Idiopathic pneumonia syndrome	31.84	15.36	8	9766	352	63478896
Type IIb hyperlipidaemia	29.17	15.36	5	9769	30	63479218
Wound secretion	28.46	15.36	14	9760	4600	63474648
Rebound effect	25.75	15.36	13	9761	4513	63474735
Cushingoid	25.40	15.36	16	9758	8469	63470779
Skin exfoliation	25.01	15.36	32	9742	43070	63436178
Type 1 diabetes mellitus	24.87	15.36	12	9762	3778	63475470
Thyroid tuberculosis	23.63	15.36	4	9770	22	63479226
Abdominal discomfort	23.51	15.36	10	9764	320875	63158373
Arthropathy	23.39	15.36	4	9770	234788	63244460
Skin lesion	23.06	15.36	26	9748	30695	63448553
Skin hyperpigmentation	22.47	15.36	13	9761	5908	63473340
Drug-induced liver injury	22.00	15.36	29	9745	40193	63439055
Pseudomonas infection	21.36	15.36	16	9758	11197	63468051
Joint swelling	21.29	15.36	12	9762	327654	63151594
Congenital hydrocephalus	21.09	15.36	5	9769	172	63479076
Klebsiella infection	20.40	15.36	14	9760	8552	63470696
Therapy partial responder	19.84	15.36	15	9759	10643	63468605
Pyoderma gangrenosum	19.42	15.36	10	9764	3615	63475633
Cyanosis	19.40	15.36	18	9756	16917	63462331
Leukopenia	19.24	15.36	39	9735	77251	63401997
Cutaneous lupus erythematosus	19.06	15.36	9	9765	2703	63476545
Eosinophilic myocarditis	18.94	15.36	6	9768	614	63478634
Hypoxia	18.37	15.36	33	9741	59759	63419489
Marrow hyperplasia	18.24	15.36	6	9768	692	63478556
Dermatitis herpetiformis	17.23	15.36	3	9771	20	63479228
Choriomeningitis lymphocytic	16.64	15.36	3	9771	25	63479223
Scar	16.47	15.36	15	9759	13767	63465481
Methylobacterium infection	16.43	15.36	3	9771	27	63479221
Therapy non-responder	16.22	15.36	36	9738	75865	63403383
Leukaemoid reaction	15.85	15.36	4	9770	179	63479069
Bronchopulmonary aspergillosis	15.74	15.36	12	9762	8623	63470625
Oxygen saturation decreased	15.65	15.36	39	9735	88546	63390702
Arthralgia	15.64	15.36	41	9733	569669	62909579

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	349.84	16.15	96	9052	3485	34944298
Drug reaction with eosinophilia and systemic symptoms	168.92	16.15	106	9042	32906	34914877
Type 2 lepra reaction	148.71	16.15	28	9120	167	34947616
Haemolytic anaemia	106.84	16.15	53	9095	10426	34937357
Vanishing bile duct syndrome	79.83	16.15	23	9125	995	34946788
Type 1 lepra reaction	72.55	16.15	12	9136	28	34947755
Nocardiosis	58.91	16.15	26	9122	3925	34943858
Brain abscess	51.27	16.15	22	9126	3103	34944680
Mycobacterium avium complex infection	48.99	16.15	20	9128	2491	34945292
Pleocytosis	45.65	16.15	13	9135	539	34947244
Drug-induced liver injury	41.20	16.15	44	9104	28788	34918995
Pyrexia	40.42	16.15	183	8965	332830	34614953
Haemolysis	38.86	16.15	25	9123	8069	34939714
Blood methaemoglobin present	33.27	16.15	6	9142	27	34947756
HIV associated nephropathy	32.83	16.15	9	9139	324	34947459
Hypoxia	31.81	16.15	54	9094	55041	34892742
Pancytopenia	30.54	16.15	73	9075	95084	34852699
Aeromonas infection	29.51	16.15	8	9140	276	34947507
Drug ineffective for unapproved indication	28.39	16.15	33	9115	23682	34924101
Toxoplasmosis	27.45	16.15	11	9137	1305	34946478
Treatment failure	27.26	16.15	46	9102	46651	34901132
Drug ineffective	26.07	16.15	206	8942	456545	34491238
Papillary cystadenoma lymphomatosum	25.38	16.15	5	9143	39	34947744
Fluid imbalance	25.37	16.15	7	9141	258	34947525
Thrombocytopenia	25.29	16.15	94	9054	156153	34791630
Jarisch-Herxheimer reaction	23.73	16.15	8	9140	583	34947200
Pneumonia pseudomonal	23.62	16.15	14	9134	3908	34943875
Induration	23.33	16.15	9	9139	966	34946817
Mucormycosis	22.86	16.15	16	9132	5926	34941857
Photophobia	22.80	16.15	17	9131	6947	34940836
Mycobacterium abscessus infection	20.41	16.15	7	9141	537	34947246
Pneumonia cryptococcal	20.41	16.15	8	9140	896	34946887
Disseminated cryptococcosis	20.27	16.15	9	9139	1377	34946406
Cushingoid	19.86	16.15	11	9137	2703	34945080
Epstein-Barr virus infection	19.31	16.15	16	9132	7612	34940171
Graft versus host disease	18.49	16.15	18	9130	10551	34937232
Autoinflammatory disease	18.31	16.15	4	9144	54	34947729
Pneumocystis jirovecii pneumonia	18.08	16.15	24	9124	19686	34928097
Choroidal effusion	18.03	16.15	5	9143	188	34947595
Polychromasia	17.45	16.15	5	9143	212	34947571
Death	16.90	16.15	51	9097	397998	34549785
Neuritis	16.73	16.15	7	9141	927	34946856
Necrotising fasciitis	16.65	16.15	11	9137	3711	34944072
Disseminated mycobacterium avium complex infection	16.61	16.15	4	9144	85	34947698

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	964.48	14.23	224	15921	5333	79722910
Drug reaction with eosinophilia and systemic symptoms	450.95	14.23	232	15913	64012	79664231
Haemolytic anaemia	246.13	14.23	103	16042	17717	79710526
Type 2 lepra reaction	190.55	14.23	34	16111	194	79728049
Blood methaemoglobin present	87.48	14.23	16	16129	107	79728136
Type 1 lepra reaction	84.95	14.23	14	16131	45	79728198
Drug ineffective	79.31	14.23	428	15717	1080485	78647758
Haemolysis	77.59	14.23	42	16103	12770	79715473
Vanishing bile duct syndrome	77.17	14.23	24	16121	1754	79726489
Off label use	76.04	14.23	373	15772	906842	78821401
Treatment failure	75.86	14.23	129	16016	170357	79557886
Nocardiosis	72.31	14.23	31	16114	5648	79722595
Drug ineffective for unapproved indication	68.46	14.23	67	16078	51171	79677072
Drug-induced liver injury	66.03	14.23	74	16071	66043	79662200
Brain abscess	47.03	14.23	22	16123	4914	79723329
Cushingoid	46.13	14.23	27	16118	9525	79718718
Sepsis	45.79	14.23	139	16006	269289	79458954
Pyrexia	44.98	14.23	262	15883	678447	79049796
Hypoxia	44.40	14.23	77	16068	103166	79625077
Pancytopenia	40.72	14.23	98	16047	165647	79562596
Product use in unapproved indication	37.79	14.23	124	16021	250235	79478008
Pseudomonas infection	36.99	14.23	32	16113	20871	79707372
Pleocytosis	36.67	14.23	13	16132	1426	79726817
Rebound effect	36.42	14.23	21	16124	7205	79721038
HIV associated nephropathy	35.01	14.23	9	16136	328	79727915
Cytomegalovirus infection	34.71	14.23	43	16102	42601	79685642
Therapy non-responder	32.31	14.23	63	16082	92242	79636001
Mycobacterium avium complex infection	30.44	14.23	16	16129	4584	79723659
Skin exfoliation	30.36	14.23	46	16099	55054	79673189
Aeromonas infection	29.32	14.23	8	16137	368	79727875
Pneumonia pseudomonal	29.32	14.23	17	16128	5894	79722349
Necrotising fasciitis	28.95	14.23	17	16128	6033	79722210
Skin odour abnormal	28.29	14.23	12	16133	2129	79726114
Type IIb hyperlipidaemia	27.80	14.23	5	16140	30	79728213
Cutaneous lupus erythematosus	27.43	14.23	13	16132	2990	79725253
Pneumocystis jirovecii pneumonia	26.81	14.23	33	16112	32475	79695768
Cyanosis	26.53	14.23	29	16116	25153	79703090
Joint swelling	25.96	14.23	13	16132	288633	79439610
Myopathy	25.81	14.23	26	16119	20537	79707706
Jarisch-Herxheimer reaction	25.74	14.23	9	16136	948	79727295
Therapy partial responder	25.59	14.23	24	16121	17373	79710870
Hydronephrosis	25.52	14.23	24	16121	17430	79710813
Thrombocytopenia	24.13	14.23	112	16033	265147	79463096
Mucormycosis	23.72	14.23	17	16128	8452	79719791
Leukocytosis	23.55	14.23	36	16109	43419	79684824
Epstein-Barr virus infection	23.37	14.23	21	16124	14395	79713848
Skin lesion	23.15	14.23	35	16110	41809	79686434
Antineutrophil cytoplasmic antibody positive	23.01	14.23	9	16136	1297	79726946
Induration	22.71	14.23	10	16135	1942	79726301
Fluid imbalance	22.28	14.23	7	16138	529	79727714
Arthralgia	22.28	14.23	52	16093	571751	79156492
Thyroid tuberculosis	22.24	14.23	4	16141	24	79728219
Anaemia	22.14	14.23	160	15985	444855	79283388
Type 1 diabetes mellitus	21.97	14.23	15	16130	6904	79721339
Leukopenia	21.55	14.23	62	16083	116451	79611792
Idiopathic pneumonia syndrome	21.55	14.23	7	16138	589	79727654
Papillary cystadenoma lymphomatosum	21.07	14.23	5	16140	130	79728113
Arthropathy	21.04	14.23	5	16140	177106	79551137
Graft versus host disease	20.71	14.23	20	16125	15006	79713237
Pain	20.15	14.23	74	16071	703728	79024515
Disseminated cryptococcosis	20.07	14.23	9	16136	1825	79726418
Respiratory failure	19.98	14.23	81	16064	180830	79547413
Toxoplasmosis	19.63	14.23	10	16135	2687	79725556
Jaundice	19.38	14.23	37	16108	53312	79674931
Hepatitis fulminant	19.03	14.23	14	16131	7248	79720995
Mucocutaneous leishmaniasis	18.84	14.23	6	16139	474	79727769
Pain in extremity	18.73	14.23	28	16117	364510	79363733
Wound secretion	18.67	14.23	13	16132	6175	79722068
Renal failure	18.37	14.23	85	16060	200883	79527360
Pneumonia cryptococcal	18.30	14.23	8	16137	1527	79726716
Staphylococcal bacteraemia	18.25	14.23	17	16128	12201	79716042
Lymphocytic infiltration	18.21	14.23	8	16137	1545	79726698
Rheumatoid arthritis	17.84	14.23	10	16135	208460	79519783
Staphylococcal infection	17.10	14.23	37	16108	58258	79669985
Rash maculo-papular	16.92	14.23	36	16109	56042	79672201
Skin hyperpigmentation	16.74	14.23	13	16132	7290	79720953
Tuberculoid leprosy	16.71	14.23	4	16141	108	79728135
Mycobacterium abscessus infection	16.65	14.23	7	16138	1215	79727028
Eosinophilic myocarditis	16.65	14.23	7	16138	1215	79727028
Pneumonia	16.49	14.23	205	15940	660041	79068202
Clostridium difficile infection	15.99	14.23	30	16115	42655	79685588
Polychromasia	15.85	14.23	5	16140	383	79727860
Plasma cell myeloma	15.85	14.23	34	16111	53225	79675018
Bronchopulmonary aspergillosis	15.81	14.23	21	16124	22273	79705970
Methylobacterium infection	15.61	14.23	3	16142	27	79728216
Peripheral swelling	15.57	14.23	19	16126	269598	79458645
Linear IgA disease	15.51	14.23	9	16136	3123	79725120
Application site discolouration	15.39	14.23	6	16139	858	79727385
Clostridium difficile colitis	15.09	14.23	25	16120	32258	79695985
Vascular cognitive impairment	15.07	14.23	3	16142	33	79728210
Pemphigoid	15.03	14.23	17	16128	15298	79712945
Klebsiella infection	14.67	14.23	17	16128	15703	79712540
Acute respiratory failure	14.38	14.23	35	16110	59506	79668737

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
ATC	J04BA50	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF LEPRA Drugs for treatment of lepra
ATC	J04BA51	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)

None

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
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
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	0713-0886	GEL	50 mg	TOPICAL	ANDA	26 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	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
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	29033-036	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	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	49938-101	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