Home Applications 200739 Application 200739
Type ANDA
Sponsor NATCO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALPRAZOLAM ALPRAZOLAM TABLET;ORAL 0.25MG No No 002 ALPRAZOLAM ALPRAZOLAM TABLET;ORAL 0.5MG No No 003 ALPRAZOLAM ALPRAZOLAM TABLET;ORAL 1MG No No 004 ALPRAZOLAM ALPRAZOLAM TABLET;ORAL 2MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200739-001 ALPRAZOLAM ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 A200739-002 ALPRAZOLAM ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 A200739-003 ALPRAZOLAM ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 A200739-004 ALPRAZOLAM ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 168 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 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200739-001 ALPRAZOLAM 0.25MG TABLET / ORAL AB 2015-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200739-002 ALPRAZOLAM 0.5MG TABLET / ORAL AB 2015-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200739-003 ALPRAZOLAM 1MG TABLET / ORAL AB 2015-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200739-004 ALPRAZOLAM 2MG TABLET / ORAL AB 2015-04-15 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alprazolam ALPRAZOLAM Natco Pharma USA LLC b3c55877-2538-4892-bdb1-d618c643d29c 2026-01-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 200739 application number: ANDA200739
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 25 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 53002-3950 Alprazolam Alprazolam RPK Pharmaceuticals, Inc. ANDA Current 53002-3950 Alprazolam Alprazolam RPK Pharmaceuticals, Inc. ANDA Current 55700-491 Alprazolam Alprazolam Lake Erie Medical DBA Quality Care Products LLC ANDA Current 61919-456 ALPRAZOLAM ALPRAZOLAM Direct Rx ANDA Current 61919-456 ALPRAZOLAM ALPRAZOLAM Direct Rx ANDA Current 63187-966 Alprazolam Alprazolam Proficient Rx LP ANDA Current 63187-966 Alprazolam Alprazolam Proficient Rx LP ANDA Current 66267-820 Alprazolam Alprazolam NuCare Pharmaceuticals,Inc. ANDA Current 66267-820 Alprazolam Alprazolam NuCare Pharmaceuticals,Inc. ANDA Current 67296-1379 Alprazolam Alprazolam RedPharm Drug, Inc. ANDA Current 67296-1379 Alprazolam Alprazolam RedPharm Drug, Inc. ANDA Current 68071-1884 Alprazolam Alprazolam NuCare Pharmaceuticals, Inc. ANDA Current 68071-1888 Alprazolam Alprazolam NuCare Pharmaceuticals, Inc. ANDA Current 68071-1966 Alprazolam Alprazolam NuCare Pharmaceuticals, Inc. ANDA Current 68071-3049 Alprazolam Alprazolam NuCare Pharmaceuticals, Inc. ANDA Current 68788-6865 Alprazolam Alprazolam Preferred Pharmaceuticals Inc. ANDA Current 69452-110 Alprazolam Alprazolam Bionpharma Inc. ANDA Current 69452-111 Alprazolam Alprazolam Bionpharma Inc. ANDA Current 69452-112 Alprazolam Alprazolam Bionpharma Inc. ANDA Current 69452-113 Alprazolam Alprazolam Bionpharma Inc. ANDA Current 71335-0163 Alprazolam Alprazolam Bryant Ranch Prepack ANDA Current 71335-0215 Alprazolam Alprazolam Bryant Ranch Prepack ANDA Current 71335-0247 Alprazolam Alprazolam Bryant Ranch Prepack ANDA Current 71335-0448 Alprazolam Alprazolam Bryant Ranch Prepack ANDA Current 71335-0850 Alprazolam Alprazolam Bryant Ranch Prepack ANDA Current