Application 213352
- Type
- ANDA
- Sponsor
- AREVA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 10MG/4ML (2.5MG/ML) | No | No |
| 002 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | SOLUTION;INTRAVENOUS | 5MG/2ML (2.5MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A213352-001 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | |
| A213352-002 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A213352-001 | AP |
| A213352-002 | AP |
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 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A213352-001 | VERAPAMIL HYDROCHLORIDE | 10MG/4ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-03-17 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A213352-002 | VERAPAMIL HYDROCHLORIDE | 5MG/2ML (2.5MG/ML) | SOLUTION / INTRAVENOUS | AP | 2020-09-16 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A213352-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A213352-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A213352-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A213352-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213352-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A213352-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A213352-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A213352-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213352-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A213352-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213352-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A213352-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213352-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A213352-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213352-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A213352-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213352-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A213352-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213352-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A213352-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A213352-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A213352-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213352-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A213352-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213352-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A213352-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213352-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A213352-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A213352-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A213352-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213352-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A213352-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A213352-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A213352-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A213352-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A213352-002 | AP | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A213352-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A213352-002 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A213352-001 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A213352-002 | AP | 1 | 782e0a99824c… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59923-605 | Verapamil Hydrochloride | Verapamil Hydrochloride | Areva Pharmaceuticals | ANDA | Current |
| 59923-605 | Verapamil Hydrochloride | Verapamil Hydrochloride | Areva Pharmaceuticals | ANDA | Current |
| 59923-605 | Verapamil Hydrochloride | Verapamil Hydrochloride | Areva Pharmaceuticals | ANDA | Current |