Home Applications 072781 Application 072781
Type ANDA
Sponsor INTERGEL PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NIFEDIPINE NIFEDIPINE CAPSULE;ORAL 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072781-001 NIFEDIPINE NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072781-001 AB
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 2 · 41 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 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072781-001 NIFEDIPINE 10MG CAPSULE / ORAL AB 1993-07-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 · 22 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42192-615 Nifedipine Nifedipine Acella Pharmaceuticals, LLC ANDA Current 43386-440 Nifedipine Nifedipine Lupin Pharmaceuticals Inc ANDA Current 50268-591 Nifedipine Nifedipine AvPAK ANDA Current 50268-591 Nifedipine Nifedipine AvPAK ANDA Current 55154-8199 Nifedipine Nifedipine Cardinal Health ANDA Current 55289-907 Nifedipine Nifedipine PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-907 Nifedipine Nifedipine PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-907 Nifedipine Nifedipine PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-907 Nifedipine Nifedipine PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-907 Nifedipine Nifedipine PD-Rx Pharmaceuticals, Inc. ANDA Current 60429-163 Nifedipine Nifedipine Golden State Medical Supply, Inc. ANDA Current 60429-163 Nifedipine Nifedipine Golden State Medical Supply, Inc. ANDA Current 60687-425 Nifedipine Nifedipine American Health Packaging ANDA Current 60687-425 Nifedipine Nifedipine American Health Packaging ANDA Current 60687-425 Nifedipine Nifedipine American Health Packaging ANDA Current 62112-8045 Nifedipine Nifedipine Intergel Pharmaceuticals Inc ANDA Current 62112-8045 Nifedipine Nifedipine Intergel Pharmaceuticals Inc ANDA Current 66267-831 Nifedipine Nifedipine NuCare Pharmaceuticals,Inc. ANDA Current 66267-831 Nifedipine Nifedipine NuCare Pharmaceuticals,Inc. ANDA Current 67296-1240 Nifedipine Nifedipine RedPharm Drug, Inc. ANDA Current 67296-1240 Nifedipine Nifedipine RedPharm Drug, Inc. ANDA Current 68151-2870 Nifedipine Nifedipine Carilion Materials Management ANDA Current