Application 211175

Type: ANDA
Sponsor: FOUGERA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TAZAROTENE	TAZAROTENE	CREAM;TOPICAL	0.1%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211175-001	TAZAROTENE	TAZAROTENE	0.1%	CREAM / TOPICAL			2019-01-28

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2019-01-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211175-001	TAZAROTENE	0.1%	CREAM / TOPICAL		2019-01-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A211175-001	AB	1	`ea99ee380514…`

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trilitas	TAZAROTENE	Perfero Pharma, Inc.	1cf1faef-73b8-4ab2-a4c8-521f0bd3fc10	2026-05-18	Warnings, Adverse reactions	Name fallback generic name: TAZAROTENE
FABIOR	TAZAROTENE	Mayne Pharma	ae0afed7-1d60-45fd-a08b-8db094618521	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: TAZAROTENE
Tazarotene	TAZAROTENE	Sun Pharmaceutical Industries, Inc.	478ff059-9d7b-438e-a64e-c853dfac2872	2025-12-19	Warnings, Adverse reactions	Name fallback brand name: Tazarotene generic name: TAZAROTENE
Tazorac	TAZAROTENE	Almirall, LLC	4e4e4b81-420e-4492-8a74-80b692a80057	2025-11-13	Warnings, Adverse reactions	Name fallback generic name: TAZAROTENE
TAZORAC	TAZAROTENE	Almirall, LLC	021744d1-a6d7-4ad6-99c2-7187c24e64c6	2025-11-13	Warnings, Adverse reactions	Name fallback generic name: TAZAROTENE
Tazarotene	TAZAROTENE	Sun Pharmaceutical Industries, Inc.	34d79c31-1568-4797-a4f5-31200c7788db	2025-07-07	Warnings, Adverse reactions	Name fallback brand name: Tazarotene generic name: TAZAROTENE
Tazarotene	TAZAROTENE	Cosette Pharmaceuticals, Inc.	fa5caf83-29d5-8229-b125-d7736928f132	2025-03-10	Warnings, Adverse reactions	Name fallback brand name: Tazarotene generic name: TAZAROTENE
Tazarotene	TAZAROTENE	Solaris Pharma Corporation	f1c98c4a-f101-4f3c-851a-39c827415c46	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Tazarotene generic name: TAZAROTENE
TAZAROTENE	TAZAROTENE	Bryant Ranch Prepack	91264c0a-223c-47b7-b537-071944f25790	2024-11-11	Warnings, Adverse reactions	Name fallback brand name: TAZAROTENE generic name: TAZAROTENE
tazarotene	TAZAROTENE	Mayne Pharma Inc.	0e337598-f589-483f-a2ae-be7c319d7454	2024-06-04	Warnings, Adverse reactions	Name fallback brand name: tazarotene generic name: TAZAROTENE
TAZAROTENE	TAZAROTENE	Padagis Israel Pharmaceuticals Ltd	df5d65de-0693-4fd2-b335-f04ab1e201e7	2024-05-31	Warnings, Adverse reactions	Name fallback brand name: TAZAROTENE generic name: TAZAROTENE
TAZAROTENE	TAZAROTENE	Bryant Ranch Prepack	aa6fff2f-01c7-4669-be67-07cec82c768a	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: TAZAROTENE generic name: TAZAROTENE
Tazarotene	TAZAROTENE	Mayne Pharma	0296f0e9-f940-45d9-987e-1ee26a7ca961	2024-03-05	Warnings, Adverse reactions	Name fallback brand name: Tazarotene generic name: TAZAROTENE
TAZAROTENE	TAZAROTENE	Padagis Israel Pharmaceuticals Ltd	ffd11dee-4266-4201-9573-1e82c2d30a63	2024-01-01	Warnings, Adverse reactions	Name fallback brand name: TAZAROTENE generic name: TAZAROTENE
TAZAROTENE	TAZAROTENE	Cosette Pharmaceuticals, Inc.	ecd718fd-c06e-4b3a-8aca-fa51e7c51a66	2023-11-29	Warnings, Adverse reactions	Name fallback brand name: TAZAROTENE generic name: TAZAROTENE
TAZAROTENE	TAZAROTENE	Cosette Pharmaceuticals, Inc.	94749b8e-0d00-4257-a660-6d0fc8815fcf	2023-11-29	Warnings, Adverse reactions	Name fallback brand name: TAZAROTENE generic name: TAZAROTENE
Arazlo	TAZAROTENE	Bausch Health US, LLC	d941ff25-c221-4a55-8012-0dcf3bbcbbd1	2023-09-26	Warnings, Adverse reactions	Name fallback generic name: TAZAROTENE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0454	TAZAROTENE	tazarotene	Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0454	TAZAROTENE	tazarotene	Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0455	Tazarotene Cream	tazarotene	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0455	Tazarotene Cream	tazarotene	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current