Home Applications 075584 Application 075584
Type ANDA
Sponsor APNAR PHARMA LP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 75MG No No 002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE TABLET;ORAL 100MG 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 A075584-001 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 A075584-002 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07
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 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075584-001 BUPROPION HYDROCHLORIDE 75MG TABLET / ORAL AB 2000-02-07 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075584-002 BUPROPION HYDROCHLORIDE 100MG TABLET / ORAL AB 2000-02-07 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 · 44 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0615-5535 Bupropion Hydrochloride Bupropion Hydrochloride NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-5554 Bupropion Hydrochloride Bupropion Hydrochloride NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0781-1053 Bupropion Hydrochloride Bupropion Hydrochloride Sandoz Inc ANDA Current 0781-1064 Bupropion Hydrochloride Bupropion Hydrochloride Sandoz Inc ANDA Current 21695-017 Bupropion Hydrochloride Bupropion Hydrochloride Rebel Distributors Corp. ANDA Current 21695-018 Bupropion Hydrochloride Bupropion Hydrochloride Rebel Distributors Corp. ANDA Current 24689-119 BupropionHydrochlorideTablets Bupropion Hydrochloride Tablets Apnar Pharma LP ANDA Current 24689-119 BupropionHydrochlorideTablets Bupropion Hydrochloride Tablets Apnar Pharma LP ANDA Current 24689-119 Bupropion Hydrochloride Bupropion Hydrochloride Apnar Pharma LP ANDA Current 24689-119 Bupropion Hydrochloride Bupropion Hydrochloride Apnar Pharma LP ANDA Current 24689-120 BupropionHydrochlorideTablets Bupropion Hydrochloride tablets Apnar Pharma LP ANDA Current 24689-120 BupropionHydrochlorideTablets Bupropion Hydrochloride tablets Apnar Pharma LP ANDA Current 24689-120 Bupropion Hydrochloride Bupropion Hydrochloride Apnar Pharma LP ANDA Current 24689-120 Bupropion Hydrochloride Bupropion Hydrochloride Apnar Pharma LP ANDA Current 33261-012 Bupropion Hydrochloride Bupropion Hydrochloride Aidarex Pharmaceuticals LLC ANDA Current 33261-013 Bupropion Hydrochloride Bupropion Hydrochloride Aidarex Pharmaceuticals LLC ANDA Current 43353-767 Bupropion Hydrochloride Bupropion Hydrochloride Aphena Pharma Solutions - Tennessee, LLC ANDA Current 49999-349 Bupropion Hydrochloride Bupropion Hydrochloride Lake Erie Medical DBA Quality Care Products LLC ANDA Current 49999-918 Bupropion Hydrochloride Bupropion Hydrochloride Lake Erie Medical DBA Quality Care Products LLC ANDA Current 50090-0785 Bupropion Hydrochloride Bupropion Hydrochloride A-S Medication Solutions ANDA Current 50436-9101 Bupropion Hydrochloride Bupropion Hydrochloride Unit Dose Services ANDA Current 53808-0215 Bupropion Hydrochloride Bupropion Hydrochloride State of Florida DOH Central Pharmacy ANDA Current 61919-037 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE DirectRX ANDA Current 61919-037 BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE DirectRX ANDA Current 63187-416 Bupropion Hydrochloride Bupropion Hydrochloride Proficient Rx LP ANDA Current 63629-2642 Bupropion Hydrochloride Bupropion Hydrochloride Bryant Ranch Prepack ANDA Current 63629-2642 Bupropion Hydrochloride Bupropion Hydrochloride Bryant Ranch Prepack ANDA Current 63629-3233 Bupropion Hydrochloride Bupropion Hydrochloride Bryant Ranch Prepack ANDA Current 63629-3233 Bupropion Hydrochloride Bupropion Hydrochloride Bryant Ranch Prepack ANDA Current 63739-706 Bupropion Hydrochloride Bupropion Hydrochloride McKesson Corporation dba SKY Packaging ANDA Current 63739-706 Bupropion Hydrochloride Bupropion Hydrochloride McKesson Corporation ANDA Current 64725-1053 Bupropion Hydrochloride Bupropion Hydrochloride TYA Pharmaceuticals ANDA Current 66267-614 Bupropion Hydrochloride Bupropion Hydrochloride NuCare Pharmaceuticals, Inc. ANDA Current 66267-614 Bupropion Hydrochloride Bupropion Hydrochloride NuCare Pharmaceuticals, Inc. ANDA Current 67046-044 Bupropion Hydrochloride Bupropion Hydrochloride Contract Pharmacy Services-PA ANDA Current 67046-045 Bupropion Hydrochloride Bupropion Hydrochloride Contract Pharmacy Services-PA ANDA Current 67544-892 Bupropion Hydrochloride Bupropion Hydrochloride Aphena Pharma Solutions - Tennessee, LLC ANDA Current 68001-198 Bupropion Hydrochloride Bupropion Hydrochloride BluePoint Laboratories ANDA Current 68001-199 Bupropion Hydrochloride Bupropion Hydrochloride BluePoint Laboratories ANDA Current 68258-7001 Bupropion Hydrochloride Bupropion Hydrochloride Dispensing Solutions, Inc. ANDA Current 68788-9781 Bupropion Hydrochloride Bupropion Hydrochloride Preferred Pharmaceuticals,Inc. ANDA Current 68788-9781 Bupropion Hydrochloride Bupropion Hydrochloride Preferred Pharmaceuticals,Inc. ANDA Current 71335-0468 Bupropion Hydrochloride Bupropion Hydrochloride Bryant Ranch Prepack ANDA Current 71335-0468 Bupropion Hydrochloride Bupropion Hydrochloride Bryant Ranch Prepack ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 23766 ORIG 2005-07-28 43006 ORIG 2001-06-07 30947 ORIG 2000-02-07