FDA.reportPublic FDA data

Application 090405

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LETROZOLELETROZOLETABLET; ORAL2.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LETROZOLELETROZOLEBreckenridge Pharmaceutical, Inc.63e54b62-a30d-4a56-9215-75e7a0b0bf022026-07-08Warnings, Adverse reactionsName fallback
brand name: LETROZOLE
generic name: LETROZOLE
LetrozoleLETROZOLECarnegie Pharmaceuticals LLCcb1da0ac-8db1-4482-824d-430511d1b7a02026-06-29Warnings, Adverse reactionsName fallback
brand name: Letrozole
generic name: LETROZOLE
LETROZOLELETROZOLEA-S Medication Solutions3baa3912-3e64-473b-8ec6-8557aa7907c22026-06-26Warnings, Adverse reactionsName fallback
brand name: LETROZOLE
generic name: LETROZOLE
LetrozoleLETROZOLEA-S Medication Solutions065cc89f-3a3f-4d78-b9f6-1c32a77ceb1c2026-06-22Warnings, Adverse reactionsName fallback
brand name: Letrozole
generic name: LETROZOLE
FemaraLETROZOLENovartis Pharmaceuticals Corporation82b77d74-085f-45ac-a7dd-1f5c038bf4062026-06-11Warnings, Adverse reactionsName fallback
generic name: LETROZOLE
LetrozoleLETROZOLE TABLETSGolden State Medical Supply, Inc.32d7dd83-a3ef-41fe-e063-6394a90ae62a2026-04-23Warnings, Adverse reactionsName fallback
brand name: Letrozole
LetrozoleLETROZOLEBryant Ranch Prepack26dcb6ee-74d8-4804-b151-79a41484979b2026-04-03Warnings, Adverse reactionsName fallback
brand name: Letrozole
generic name: LETROZOLE
LetrozoleLETROZOLE TABLETSUpsher-Smith Laboratories, LLC2d1f18f0-2c77-407c-b702-2d1b07f925102026-03-19Warnings, Adverse reactionsName fallback
brand name: Letrozole
LetrozoleLETROZOLEAccord Healthcare, Inc.c391fe11-fd47-4a35-af6d-c823ab7b88382026-02-09Warnings, Adverse reactionsName fallback
brand name: Letrozole
generic name: LETROZOLE
LETROZOLELETROZOLEAvPAK93f317f1-96d1-498e-e053-2995a90ac60d2026-01-20Warnings, Adverse reactionsName fallback
brand name: LETROZOLE
generic name: LETROZOLE
LetrozoleLETROZOLE TABLETSYiling Pharmaceutical, Inc.7b00e08c-9a1c-09e0-e053-2a91aa0a76382025-12-29Warnings, Adverse reactionsName fallback
brand name: Letrozole
LETROZOLELETROZOLEChartwell RX, LLCfa2d40a5-3504-44ef-8f5c-aa4c063080742025-12-08Warnings, Adverse reactionsName fallback
brand name: LETROZOLE
generic name: LETROZOLE
LetrozoleLETROZOLEAvKARE1524730f-e37d-478c-1956-b113b3ca42a82025-11-19Warnings, Adverse reactionsName fallback
brand name: Letrozole
generic name: LETROZOLE
LetrozoleLETROZOLE TABLETSAvet Pharmaceuticals Inc.fe0e4d4b-436d-a36d-e053-6294a90a973d2025-09-30Warnings, Adverse reactionsName fallback
brand name: Letrozole
LetrozoleLETROZOLEATLANTIC BIOLOGICALS CORP.c10bf97f-f9cf-468a-8a1f-7637f41022e42025-06-24Warnings, Adverse reactionsName fallback
brand name: Letrozole
generic name: LETROZOLE
LetrozoleLETROZOLEAurobindo Pharma Limitedff7325d2-3383-4ff9-a187-9350e35386402025-03-28Warnings, Adverse reactionsName fallback
brand name: Letrozole
generic name: LETROZOLE
LetrozoleLETROZOLE TABLETSBryant Ranch Prepack6fd92634-c9c5-457e-808c-a4614e8db7db2025-01-31Warnings, Adverse reactionsName fallback
brand name: Letrozole
LetrozoleLETROZOLENuCare Pharmaceuticals,Inc.a707ec4b-8d26-55c2-e053-2a95a90a2e072024-12-30Warnings, Adverse reactionsName fallback
brand name: Letrozole
generic name: LETROZOLE
LetrozoleLETROZOLETeva Pharmaceuticals USA, Inc.8ebda73d-82a3-4b17-8a81-a1f258003d322024-12-30Warnings, Adverse reactionsName fallback
brand name: Letrozole
generic name: LETROZOLE
LetrozoleLETROZOLENuCare Pharmaceuticals,Inc.1b408ba8-05f7-1cf1-e063-6394a90a42bc2024-06-19Warnings, Adverse reactionsName fallback
brand name: Letrozole
generic name: LETROZOLE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65841-744letrozoleletrozoleCadila Healthcare LimitedANDACurrent
68382-363letrozoleletrozoleZydus Pharmaceuticals (USA) Inc.ANDACurrent