SULFANILAMIDE - Generic Drug Details

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What are the generic sources for sulfanilamide and what is the scope of freedom to operate?

Sulfanilamide is the generic ingredient in two branded drugs marketed by Norvium Bioscience and Cosette, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for sulfanilamide.

Summary for SULFANILAMIDE

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	6
Raw Ingredient (Bulk) Api Vendors:	174
Clinical Trials:	1
Patent Applications:	6,378
DailyMed Link:	SULFANILAMIDE at DailyMed

Recent Clinical Trials for SULFANILAMIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Beijing Jishuitan Hospital	Phase 4
Xuanwu Hospital, Beijing	Phase 4
Peking University First Hospital	Phase 4

See all SULFANILAMIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for SULFANILAMIDE

D06BA	Sulfonamides
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

J01EB	Short-acting sulfonamides
J01E	SULFONAMIDES AND TRIMETHOPRIM
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for SULFANILAMIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	AVC	sulfanilamide	CREAM;VAGINAL	006530-003	Jan 27, 1987		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	AVC	sulfanilamide	SUPPOSITORY;VAGINAL	006530-004	Jan 27, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cosette	SULFANILAMIDE	sulfanilamide	CREAM;VAGINAL	088718-001	Sep 19, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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