FDA.reportPublic FDA data

Application 214560

Type
ANDA
Sponsor
SOLARIS PHARMA CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAZAROTENETAZAROTENECREAM;TOPICAL0.05%NoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214560-001TAZAROTENETAZAROTENE0.05%CREAM / TOPICALAB2025-11-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A214560-001AB

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
2026-09-14 22:38:342026-08A214560-001TAZAROTENE0.05%CREAM / TOPICALAB2025-11-2484e616aacf4f…
2026-08-18 06:07:402026-07A214560-001TAZAROTENE0.05%CREAM / TOPICALAB2025-11-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214560-001TAZAROTENE0.05%CREAM / TOPICALAB2025-11-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214560-001TAZAROTENE0.05%CREAM / TOPICALAB2025-11-2431067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214560-001TAZAROTENE0.05%CREAM / TOPICALAB2025-11-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A214560-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A214560-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214560-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214560-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214560-001AB1a50c72e98297…

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
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

Reported adverse events (FAERS/openFDA)#

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