FDA.reportPublic FDA data

Application 211175

Type
ANDA
Sponsor
FOUGERA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAZAROTENETAZAROTENECREAM;TOPICAL0.1%NoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211175-001TAZAROTENETAZAROTENE0.1%CREAM / TOPICAL2019-01-28

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A211175-001TAZAROTENE0.1%CREAM / TOPICAL2019-01-28a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrilitasTAZAROTENEPerfero Pharma, Inc.1cf1faef-73b8-4ab2-a4c8-521f0bd3fc102026-05-18Warnings, Adverse reactionsName fallback
generic name: TAZAROTENE
FABIORTAZAROTENEMayne Pharmaae0afed7-1d60-45fd-a08b-8db0946185212026-03-03Warnings, Adverse reactionsName fallback
generic name: TAZAROTENE
TazaroteneTAZAROTENESun Pharmaceutical Industries, Inc.478ff059-9d7b-438e-a64e-c853dfac28722025-12-19Warnings, Adverse reactionsName fallback
brand name: Tazarotene
generic name: TAZAROTENE
TazoracTAZAROTENEAlmirall, LLC4e4e4b81-420e-4492-8a74-80b692a800572025-11-13Warnings, Adverse reactionsName fallback
generic name: TAZAROTENE
TAZORACTAZAROTENEAlmirall, LLC021744d1-a6d7-4ad6-99c2-7187c24e64c62025-11-13Warnings, Adverse reactionsName fallback
generic name: TAZAROTENE
TazaroteneTAZAROTENESun Pharmaceutical Industries, Inc.34d79c31-1568-4797-a4f5-31200c7788db2025-07-07Warnings, Adverse reactionsName fallback
brand name: Tazarotene
generic name: TAZAROTENE
TazaroteneTAZAROTENECosette Pharmaceuticals, Inc.fa5caf83-29d5-8229-b125-d7736928f1322025-03-10Warnings, Adverse reactionsName fallback
brand name: Tazarotene
generic name: TAZAROTENE
TazaroteneTAZAROTENESolaris Pharma Corporationf1c98c4a-f101-4f3c-851a-39c827415c462025-01-02Warnings, Adverse reactionsName fallback
brand name: Tazarotene
generic name: TAZAROTENE
TAZAROTENETAZAROTENEBryant Ranch Prepack91264c0a-223c-47b7-b537-071944f257902024-11-11Warnings, Adverse reactionsName fallback
brand name: TAZAROTENE
generic name: TAZAROTENE
tazaroteneTAZAROTENEMayne Pharma Inc.0e337598-f589-483f-a2ae-be7c319d74542024-06-04Warnings, Adverse reactionsName fallback
brand name: tazarotene
generic name: TAZAROTENE
TAZAROTENETAZAROTENEPadagis Israel Pharmaceuticals Ltddf5d65de-0693-4fd2-b335-f04ab1e201e72024-05-31Warnings, Adverse reactionsName fallback
brand name: TAZAROTENE
generic name: TAZAROTENE
TAZAROTENETAZAROTENEBryant Ranch Prepackaa6fff2f-01c7-4669-be67-07cec82c768a2024-05-29Warnings, Adverse reactionsName fallback
brand name: TAZAROTENE
generic name: TAZAROTENE
TazaroteneTAZAROTENEMayne Pharma0296f0e9-f940-45d9-987e-1ee26a7ca9612024-03-05Warnings, Adverse reactionsName fallback
brand name: Tazarotene
generic name: TAZAROTENE
TAZAROTENETAZAROTENEPadagis Israel Pharmaceuticals Ltdffd11dee-4266-4201-9573-1e82c2d30a632024-01-01Warnings, Adverse reactionsName fallback
brand name: TAZAROTENE
generic name: TAZAROTENE
TAZAROTENETAZAROTENECosette Pharmaceuticals, Inc.ecd718fd-c06e-4b3a-8aca-fa51e7c51a662023-11-29Warnings, Adverse reactionsName fallback
brand name: TAZAROTENE
generic name: TAZAROTENE
TAZAROTENETAZAROTENECosette Pharmaceuticals, Inc.94749b8e-0d00-4257-a660-6d0fc8815fcf2023-11-29Warnings, Adverse reactionsName fallback
brand name: TAZAROTENE
generic name: TAZAROTENE
ArazloTAZAROTENEBausch Health US, LLCd941ff25-c221-4a55-8012-0dcf3bbcbbd12023-09-26Warnings, Adverse reactionsName 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0454TAZAROTENEtazaroteneFougera Pharmaceuticals Inc.ANDACurrent
0168-0454TAZAROTENEtazaroteneFougera Pharmaceuticals Inc.ANDACurrent
0168-0455Tazarotene CreamtazaroteneE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0455Tazarotene CreamtazaroteneE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent