Home Applications 074732 Application 074732
Type ANDA
Sponsor MYLAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TAMOXIFEN CITRATE TAMOXIFEN CITRATE TABLET;ORAL EQ 20MG BASE No No 002 TAMOXIFEN CITRATE TAMOXIFEN CITRATE TABLET;ORAL EQ 10MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074732-001 TAMOXIFEN CITRATE TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 A074732-002 TAMOXIFEN CITRATE TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074732-001 TAMOXIFEN CITRATE EQ 20MG BASE TABLET / ORAL AB 2003-02-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A074732-002 TAMOXIFEN CITRATE EQ 10MG BASE TABLET / ORAL AB 2003-02-20 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-0144 Tamoxifen Citrate Tamoxifen Citrate Mylan Pharmaceuticals Inc. ANDA Current 0378-0144 Tamoxifen Citrate Tamoxifen Citrate Mylan Pharmaceuticals Inc. ANDA Current 0378-0144 Tamoxifen Citrate Tamoxifen Citrate Mylan Pharmaceuticals Inc. ANDA Current 0378-0274 Tamoxifen Citrate Tamoxifen Citrate Mylan Pharmaceuticals Inc. ANDA Current 0378-0274 Tamoxifen Citrate Tamoxifen Citrate Mylan Pharmaceuticals Inc. ANDA Current 0378-0274 Tamoxifen Citrate Tamoxifen Citrate Mylan Pharmaceuticals Inc. ANDA Current 70518-2721 Tamoxifen Citrate Tamoxifen Citrate REMEDYREPACK INC. ANDA Current 70518-2721 Tamoxifen Citrate Tamoxifen Citrate REMEDYREPACK INC. ANDA Current 70518-2721 Tamoxifen Citrate Tamoxifen Citrate REMEDYREPACK INC. ANDA Current 71335-0893 Tamoxifen Citrate Tamoxifen Citrate Bryant Ranch Prepack ANDA Current 71335-0893 Tamoxifen Citrate Tamoxifen Citrate Bryant Ranch Prepack ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8438 ORIG 2004-06-18