Application 006530

Type: NDA
Sponsor: MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	AVC	SULFANILAMIDE	CREAM;VAGINAL	15%	Yes	Yes
004	AVC	SULFANILAMIDE	SUPPOSITORY;VAGINAL	1.05GM	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N006530-003	AVC	SULFANILAMIDE	15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL		RLD	1987-01-27
N006530-004	AVC	SULFANILAMIDE	1.05GM	SUPPOSITORY / VAGINAL			1987-01-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N006530-003	AVC	15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006530-003	AVC	15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N006530-003	AVC	15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006530-003	AVC	15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006530-003	AVC	15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N006530-003	AVC	15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N006530-003	AVC	15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N006530-003	AVC	15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N006530-003	AVC	15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N006530-003	AVC	15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N006530-003	AVC	15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N006530-003	AVC	15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N006530-003	AVC	15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N006530-003	AVC	15% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / VAGINAL	RLD	1987-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N006530-003	AVC	15%	CREAM / VAGINAL	RLD	1987-01-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N006530-003	AVC	15%	CREAM / VAGINAL	RLD	1987-01-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N006530-003	AVC	15%	CREAM / VAGINAL	RLD	1987-01-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N006530-003	AVC	15%	CREAM / VAGINAL	RLD, RS	1987-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N006530-003	AVC	15%	CREAM / VAGINAL	RLD	1987-01-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N006530-003	AVC	15%	CREAM / VAGINAL	RLD	1987-01-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N006530-004	AVC	1.05GM	SUPPOSITORY / VAGINAL		1987-01-27	`782e0a99824c…`

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0037-6631	AVC	sulfanilamide	Meda Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32943	SUPPL	2013-01-23