Home Applications 074582 Application 074582
Type ANDA
Sponsor BARR Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DANAZOL DANAZOL CAPSULE;ORAL 200MG No Yes 002 DANAZOL DANAZOL CAPSULE;ORAL 100MG No No 003 DANAZOL DANAZOL CAPSULE;ORAL 50MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074582-001 DANAZOL DANAZOL 200MG CAPSULE / ORAL AB RS 1996-08-09 A074582-002 DANAZOL DANAZOL 100MG CAPSULE / ORAL AB 1998-05-29 A074582-003 DANAZOL DANAZOL 50MG CAPSULE / ORAL AB 1998-05-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 2026-08-18 06:07:40 2026-07 A074582-001 DANAZOL 200MG CAPSULE / ORAL AB RS 1996-08-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074582-002 DANAZOL 100MG CAPSULE / ORAL AB 1998-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074582-003 DANAZOL 50MG CAPSULE / ORAL AB 1998-05-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074582-001 DANAZOL 200MG CAPSULE / ORAL AB RS 1996-08-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074582-002 DANAZOL 100MG CAPSULE / ORAL AB 1998-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074582-003 DANAZOL 50MG CAPSULE / ORAL AB 1998-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074582-001 DANAZOL 200MG CAPSULE / ORAL AB RS 1996-08-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074582-002 DANAZOL 100MG CAPSULE / ORAL AB 1998-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074582-003 DANAZOL 50MG CAPSULE / ORAL AB 1998-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074582-001 DANAZOL 200MG CAPSULE / ORAL AB RS 1996-08-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074582-002 DANAZOL 100MG CAPSULE / ORAL AB 1998-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074582-003 DANAZOL 50MG CAPSULE / ORAL AB 1998-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074582-001 DANAZOL 200MG CAPSULE / ORAL AB RS 1996-08-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074582-002 DANAZOL 100MG CAPSULE / ORAL AB 1998-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074582-003 DANAZOL 50MG CAPSULE / ORAL AB 1998-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074582-001 DANAZOL 200MG CAPSULE / ORAL AB RS 1996-08-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074582-002 DANAZOL 100MG CAPSULE / ORAL AB 1998-05-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074582-003 DANAZOL 50MG CAPSULE / ORAL AB 1998-05-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074582-001 DANAZOL 200MG CAPSULE / ORAL AB RS 1996-08-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074582-002 DANAZOL 100MG CAPSULE / ORAL AB 1998-05-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074582-003 DANAZOL 50MG CAPSULE / ORAL AB 1998-05-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074582-001 DANAZOL 200MG CAPSULE / ORAL AB RS 1996-08-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074582-002 DANAZOL 100MG CAPSULE / ORAL AB 1998-05-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074582-003 DANAZOL 50MG CAPSULE / ORAL AB 1998-05-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074582-001 DANAZOL 200MG CAPSULE / ORAL AB RS 1996-08-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074582-002 DANAZOL 100MG CAPSULE / ORAL AB 1998-05-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074582-003 DANAZOL 50MG CAPSULE / ORAL AB 1998-05-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074582-001 DANAZOL 200MG CAPSULE / ORAL AB RS 1996-08-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074582-002 DANAZOL 100MG CAPSULE / ORAL AB 1998-05-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074582-003 DANAZOL 50MG CAPSULE / ORAL AB 1998-05-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074582-001 DANAZOL 200MG CAPSULE / ORAL AB RS 1996-08-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074582-002 DANAZOL 100MG CAPSULE / ORAL AB 1998-05-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074582-003 DANAZOL 50MG CAPSULE / ORAL AB 1998-05-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074582-001 DANAZOL 200MG CAPSULE / ORAL AB RS 1996-08-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074582-002 DANAZOL 100MG CAPSULE / ORAL AB 1998-05-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074582-003 DANAZOL 50MG CAPSULE / ORAL AB 1998-05-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074582-001 DANAZOL 200MG CAPSULE / ORAL AB RS 1996-08-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074582-002 DANAZOL 100MG CAPSULE / ORAL AB 1998-05-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074582-003 DANAZOL 50MG CAPSULE / ORAL AB 1998-05-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074582-001 DANAZOL 200MG CAPSULE / ORAL AB RS 1996-08-09 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 · 20 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0555-0633 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0633 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0633 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0633 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0633 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0633 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0634 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0634 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0634 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0634 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0634 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0634 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0635 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0635 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0635 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0635 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0635 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 0555-0635 Danazol Danazol Teva Pharmaceuticals USA, Inc. ANDA Current 42291-243 Danazol Danazol AvKARE, Inc. ANDA Current 42291-243 Danazol Danazol AvKARE ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 42856 ORIG 2003-08-01