FDA.reportPublic FDA data

Application 090732

Type
ANDA
Sponsor
NEOPHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANASTROZOLEANASTROZOLETABLET;ORAL1MGNoNo

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
A090732-001ANASTROZOLEANASTROZOLE1MGTABLET / ORAL2010-06-28

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A090732-001ANASTROZOLE1MGTABLET / ORAL2010-06-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090732-001ANASTROZOLE1MGTABLET / ORAL2010-06-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090732-001ANASTROZOLE1MGTABLET / ORAL2010-06-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A090732-001AB174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A090732-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090732-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090732-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090732-001AB1ea99ee380514…

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 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANASTROZOLEANASTROZOLEBryant Ranch Prepack1d1d5818-1594-4f54-90a9-ae9a9afcdc672026-08-20Warnings, Adverse reactionsName fallback
brand name: ANASTROZOLE
generic name: ANASTROZOLE
ANASTROZOLEANASTROZOLEBreckenridge Pharmaceutical, Inc.ca9d4aff-ffdf-4a46-ad20-e47e5886a19e2026-08-18Warnings, Adverse reactionsName fallback
brand name: ANASTROZOLE
generic name: ANASTROZOLE
ANASTROZOLEANASTROZOLEPD-Rx Pharmaceuticals, Inc.5d4f90d4-e535-4681-a863-3d774a2064e62026-08-07Warnings, Adverse reactionsName fallback
brand name: ANASTROZOLE
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEPD-Rx Pharmaceuticals, Inc.54da5c12-cfaf-7a14-e063-6394a90a36352026-08-05Warnings, Adverse reactionsName fallback
brand name: Anastrozole
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEDirect_Rx58390d1f-7390-a21f-e063-6294a90a04792026-08-04Warnings, Adverse reactionsName fallback
brand name: Anastrozole
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEPD-Rx Pharmaceuticals, Inc.aabd8f88-2b52-4d43-8dc6-61605988c4dc2026-07-07Warnings, Adverse reactionsName fallback
brand name: Anastrozole
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEBryant Ranch Prepackf5b53383-0366-4ae2-9aa4-88b56c0bbd072026-06-18Warnings, Adverse reactionsName fallback
brand name: Anastrozole
generic name: ANASTROZOLE
AnastrozoleANASTROZOLE TABLETSASCLEMED USA INC.39df1668-8344-4c42-9bd7-7907bd571f6e2026-06-15Warnings, Adverse reactionsName fallback
brand name: Anastrozole
ANASTROZOLEANASTROZOLENuCare Pharmaceuticals,Inc.69be1c52-93db-e2c3-e053-2a91aa0af7742026-05-28Warnings, Adverse reactionsName fallback
brand name: ANASTROZOLE
generic name: ANASTROZOLE
AnastrozoleANASTROZOLE TABLETSNuCare Pharmaceuticals, Inc.513e8413-af48-4acc-e063-6294a90a24b42026-05-07Warnings, Adverse reactionsName fallback
brand name: Anastrozole
ANASTROZOLEANASTROZOLEAvPAK94a46579-0d79-89c7-e053-2995a90a64672026-03-10Warnings, Adverse reactionsName fallback
brand name: ANASTROZOLE
generic name: ANASTROZOLE
ARIMIDEXANASTROZOLEANI Pharmaceuticals, Inc.acbfaaa9-503c-4691-9828-76a7146ed6de2026-03-02Warnings, Adverse reactionsName fallback
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEAsclemed USA, Inc.b964f555-25d2-47ad-8942-f195f062445c2026-02-14Warnings, Adverse reactionsName fallback
brand name: Anastrozole
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEAccord Healthcare Inc.03586c40-eb32-45c5-beb7-6762a6b787902026-02-11Warnings, Adverse reactionsName fallback
brand name: Anastrozole
generic name: ANASTROZOLE
AnastrozoleANASTROZOLEAvKAREa0c2672b-e07b-4f6c-e053-2a95a90a2e5d2026-01-14Warnings, Adverse reactionsName fallback
brand name: Anastrozole
generic name: ANASTROZOLE
ANASTROZOLEANASTROZOLEAvKAREf40b925f-9f43-321d-e053-2a95a90aca8b2026-01-13Warnings, Adverse reactionsName fallback
brand name: ANASTROZOLE
generic name: ANASTROZOLE
AnastrozoleANASTROZOLE TABLETSAvet Pharmaceuticals Incf86d2158-b078-3f74-e053-6394a90aa4b62025-12-29Warnings, Adverse reactionsName fallback
brand name: Anastrozole
AnastrozoleANASTROZOLE TABLETSYiling Pharmaceutical, Inc.7b3da447-8e7c-2aaa-e053-2a91aa0a28212025-12-29Warnings, Adverse reactionsName fallback
brand name: Anastrozole
AnastrozoleANASTROZOLEChartwell RX, LLCda6ae05c-81e9-492a-a4c9-be3f1f367b592025-12-09Warnings, Adverse reactionsName fallback
brand name: Anastrozole
generic name: ANASTROZOLE
AnastrozoleANASTROZOLE TABLETSProficient Rx LP2df2aa01-1fe7-477c-9a23-699879b0b9182025-09-01Warnings, Adverse reactionsName fallback
brand name: Anastrozole

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31490ORIG2010-06-30