Application 203126
- Type
- ANDA
- Sponsor
- TWI PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NIFEDIPINE | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 002 | NIFEDIPINE | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 60MG | No | No |
| 003 | NIFEDIPINE | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 90MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203126-001 | NIFEDIPINE | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | |
| A203126-002 | NIFEDIPINE | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | |
| A203126-003 | NIFEDIPINE | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203126-001 | AB2 |
| A203126-002 | AB2 |
| A203126-003 | AB2 |
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.
| 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 | A203126-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203126-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203126-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203126-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203126-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203126-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203126-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203126-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203126-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203126-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203126-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203126-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203126-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203126-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203126-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203126-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203126-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203126-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203126-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203126-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203126-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203126-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203126-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203126-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203126-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203126-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203126-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203126-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203126-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203126-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203126-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203126-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203126-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203126-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203126-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203126-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203126-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203126-002 | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203126-003 | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203126-001 | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | AB2 | 2014-04-03 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A203126-001 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203126-002 | AB2 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203126-003 | AB2 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203126-001 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203126-002 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203126-003 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203126-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203126-002 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203126-003 | AB2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203126-001 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203126-002 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203126-003 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203126-001 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203126-002 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203126-003 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203126-001 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203126-002 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203126-003 | AB2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203126-001 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203126-002 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203126-003 | AB2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203126-001 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203126-002 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203126-003 | AB2 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203126-001 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203126-002 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203126-003 | AB2 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203126-001 | AB2 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203126-002 | AB2 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203126-003 | AB2 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203126-001 | AB2 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203126-002 | AB2 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203126-003 | AB2 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203126-001 | AB2 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203126-002 | AB2 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203126-003 | AB2 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203126-001 | AB2 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203126-002 | AB2 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203126-003 | AB2 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203126-001 | AB2 | 1 | 1e350fbaab3a… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nifedipine | NIFEDIPINE | Major Pharmaceuticals | b885b6b5-71c6-4799-8b23-5ee8c17938a0 | 2026-03-03 | Warnings, Adverse reactions | 203126 ANDA203126 0904-7208 |
| Nifedipine | NIFEDIPINE | Upsher-Smith Laboratories, LLC | 160271a8-7922-2107-e054-00144ff88e88 | 2026-01-19 | Warnings, Adverse reactions | 203126 ANDA203126 24979-011 24979-009 24979-010 |
| Nifedipine | NIFEDIPINE | Upsher-Smith Laboratories, LLC | 3bf4282f-b063-4d35-8ef0-6f48b98e9deb | 2026-01-19 | Warnings, Adverse reactions | 203126 ANDA203126 24979-011 24979-009 24979-010 |
| Nifedipine | NIFEDIPINE | Northwind Health Company, LLC | da565525-c77a-0571-e053-2995a90aaa11 | 2026-01-01 | Warnings, Adverse reactions | 203126 ANDA203126 |
| Nifedipine | NIFEDIPINE | Northwind Health Company, LLC | e3b04484-f330-9523-e053-2995a90a0e45 | 2026-01-01 | Warnings, Adverse reactions | 203126 ANDA203126 |
| Nifedipine | NIFEDIPINE | Golden State Medical Supply, Inc. | a84be46e-bb0c-d59f-e053-2a95a90aabde | 2025-12-11 | Warnings, Adverse reactions | 203126 ANDA203126 60429-047 60429-048 60429-049 |
| Nifedipine | NIFEDIPINE | NuCare Pharmaceuticals,Inc. | 5927fcff-9d1a-8322-e053-2991aa0ad289 | 2024-07-18 | Warnings, Adverse reactions | 203126 ANDA203126 68071-4097 |
| Nifedipine | NIFEDIPINE | Bryant Ranch Prepack | 6a68f67f-5b68-4f83-aad8-fc3177f5a0a4 | 2023-10-25 | Warnings, Adverse reactions | 203126 ANDA203126 |
| Nifedipine | NIFEDIPINE | Bryant Ranch Prepack | 4c4f8a8e-3995-4d2e-85d4-b6a45f5fac3e | 2023-05-08 | Warnings, Adverse reactions | 203126 ANDA203126 |
| Nifedipine | NIFEDIPINE | Proficient Rx LP | d428aa4d-4cc0-4b1e-b9f6-40ae65a735d6 | 2022-03-01 | Warnings, Adverse reactions | 203126 ANDA203126 71205-963 71205-964 |
| Nifedipine | NIFEDIPINE | Proficient Rx LP | 838d6e8f-37b0-48d3-b701-c4fa32a87b85 | 2020-02-01 | Warnings, Adverse reactions | 203126 ANDA203126 71205-412 |
| Nifedipine | NIFEDIPINE | Aphena Pharma Solutions - Tennessee, LLC | 09a04e5f-d3b0-4ee3-b12d-f74203262179 | 2019-06-06 | Warnings, Adverse reactions | 203126 ANDA203126 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-7208 | Nifedipine | Nifedipine | Major Pharmaceuticals | ANDA | Current |
| 0904-7208 | Nifedipine | Nifedipine | Major Pharmaceuticals | ANDA | Current |
| 24979-009 | Nifedipine | Nifedipine | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-009 | Nifedipine | Nifedipine | TWI Pharmaceuticals, Inc. | ANDA | Current |
| 24979-009 | Nifedipine | Nifedipine | TWI Pharmaceuticals, Inc. | ANDA | Current |
| 24979-009 | Nifedipine | Nifedipine | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-009 | Nifedipine | Nifedipine | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-009 | Nifedipine | Nifedipine | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-009 | Nifedipine | Nifedipine | TWI Pharmaceuticals, Inc. | ANDA | Current |
| 24979-009 | Nifedipine | Nifedipine | TWI Pharmaceuticals, Inc. | ANDA | Current |
| 24979-010 | Nifedipine | Nifedipine | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-010 | Nifedipine | Nifedipine | TWI Pharmaceuticals, Inc. | ANDA | Current |
| 24979-010 | Nifedipine | Nifedipine | TWI Pharmaceuticals, Inc. | ANDA | Current |
| 24979-010 | Nifedipine | Nifedipine | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-010 | Nifedipine | Nifedipine | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-010 | Nifedipine | Nifedipine | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-010 | Nifedipine | Nifedipine | TWI Pharmaceuticals, Inc. | ANDA | Current |
| 24979-010 | Nifedipine | Nifedipine | TWI Pharmaceuticals, Inc. | ANDA | Current |
| 24979-011 | Nifedipine | Nifedipine | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-011 | Nifedipine | Nifedipine | TWI Pharmaceuticals, Inc. | ANDA | Current |
| 24979-011 | Nifedipine | Nifedipine | TWI Pharmaceuticals, Inc. | ANDA | Current |
| 24979-011 | Nifedipine | Nifedipine | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-011 | Nifedipine | Nifedipine | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-011 | Nifedipine | Nifedipine | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-011 | Nifedipine | Nifedipine | TWI Pharmaceuticals, Inc. | ANDA | Current |
| 24979-011 | Nifedipine | Nifedipine | TWI Pharmaceuticals, Inc. | ANDA | Current |
| 50090-1843 | Nifedipine | Nifedipine | A-S Medication Solutions | ANDA | Current |
| 50090-1843 | Nifedipine | Nifedipine | A-S Medication Solutions | ANDA | Current |
| 50090-5328 | Nifedipine | Nifedipine | A-S Medication Solutions | ANDA | Current |
| 50090-5328 | Nifedipine | Nifedipine | A-S Medication Solutions | ANDA | Current |
| 50090-5328 | Nifedipine | Nifedipine | A-S Medication Solutions | ANDA | Current |
| 55700-401 | Nifedipine | Nifedipine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60429-047 | Nifedipine | Nifedipine | Golden State Medical Supply | ANDA | Current |
| 60429-047 | Nifedipine | Nifedipine | Golden State Medical Supply | ANDA | Current |
| 60429-047 | Nifedipine | Nifedipine | Golden State Medical Supply | ANDA | Current |
| 60429-047 | Nifedipine | Nifedipine | Golden State Medical Supply | ANDA | Current |
| 60429-047 | Nifedipine | Nifedipine | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-048 | Nifedipine | Nifedipine | Golden State Medical Supply | ANDA | Current |
| 60429-048 | Nifedipine | Nifedipine | Golden State Medical Supply | ANDA | Current |
| 60429-048 | Nifedipine | Nifedipine | Golden State Medical Supply | ANDA | Current |
| 60429-048 | Nifedipine | Nifedipine | Golden State Medical Supply | ANDA | Current |
| 60429-048 | Nifedipine | Nifedipine | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-049 | Nifedipine | Nifedipine | Golden State Medical Supply | ANDA | Current |
| 60429-049 | Nifedipine | Nifedipine | Golden State Medical Supply | ANDA | Current |
| 60429-049 | Nifedipine | Nifedipine | Golden State Medical Supply | ANDA | Current |
| 60429-049 | Nifedipine | Nifedipine | Golden State Medical Supply | ANDA | Current |
| 60429-049 | Nifedipine | Nifedipine | Golden State Medical Supply, Inc. | ANDA | Current |
| 61919-192 | NIFEDIPINE | NIFEDIPINE | DIRECT RX | ANDA | Current |
| 61919-192 | NIFEDIPINE | NIFEDIPINE | DIRECT RX | ANDA | Current |
| 61919-319 | NIFEDIPINE | NIFEDIPINE | DIRECT RX | ANDA | Current |
| 61919-319 | NIFEDIPINE | NIFEDIPINE | DIRECT RX | ANDA | Current |
| 66267-322 | Nifedipine | Nifedipine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-322 | Nifedipine | Nifedipine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-508 | Nifedipine | Nifedipine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-508 | Nifedipine | Nifedipine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-684 | Nifedipine | Nifedipine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-684 | Nifedipine | Nifedipine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3281 | NIFEdipine | NIFEdipine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3281 | NIFEdipine | NIFEdipine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3281 | NIFEdipine | NIFEdipine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3347 | Nifedipine | Nifedipine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3347 | Nifedipine | Nifedipine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3347 | Nifedipine | Nifedipine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4097 | Nifedipine | Nifedipine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4097 | Nifedipine | Nifedipine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4097 | Nifedipine | Nifedipine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6773 | Nifedipine | Nifedipine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6971 | Nifedipine | Nifedipine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6971 | Nifedipine | Nifedipine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6971 | Nifedipine | Nifedipine | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0694 | Nifedipine | Nifedipine | REMEDYREPACK INC. | ANDA | Current |
| 70518-0694 | Nifedipine | Nifedipine | REMEDYREPACK INC. | ANDA | Current |
| 70934-577 | Nifedipine | Nifedipine | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-603 | Nifedipine | Nifedipine | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-604 | Nifedipine | Nifedipine | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71205-412 | Nifedipine | Nifedipine | Proficient Rx LP | ANDA | Current |
| 71205-963 | Nifedipine | Nifedipine | Proficient Rx LP | ANDA | Current |
| 71205-963 | Nifedipine | Nifedipine | Proficient Rx LP | ANDA | Current |
| 71205-963 | Nifedipine | Nifedipine | Proficient Rx LP | ANDA | Current |
| 71205-964 | Nifedipine | Nifedipine | Proficient Rx LP | ANDA | Current |