Application 200923

Type: ANDA
Sponsor: PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GYNAZOLE-1	BUTOCONAZOLE NITRATE	CREAM;VAGINAL	2%	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200923-001	GYNAZOLE-1	BUTOCONAZOLE NITRATE	2%	CREAM / VAGINAL		RS	2012-05-18

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200923-001	GYNAZOLE-1	2%	CREAM / VAGINAL	RS	2012-05-18	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
gynazole 1	BUTOCONAZOLE NITRATE	Padagis Israel Pharmaceuticals Ltd	125d8ede-db38-4eb9-a6be-19208687f36a	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200923 application number: ANDA200923 ndc (product): 45802-396

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-396	gynazole 1	butoconazole nitrate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-396	gynazole 1	butoconazole nitrate	Perrigo New York Inc	ANDA	Current
45802-396	gynazole 1	butoconazole nitrate	Perrigo New York Inc	ANDA	Current