Application 219252
- Type
- ANDA
- Sponsor
- ZYDUS LIFESCIENCES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 120MG | No | No |
| 002 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 180MG | No | No |
| 003 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 240MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219252-001 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-11-24 | |
| A219252-002 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-11-24 | |
| A219252-003 | VERAPAMIL HYDROCHLORIDE | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-11-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219252-001 | AB |
| A219252-002 | AB |
| A219252-003 | 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.
| 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 | A219252-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-11-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219252-002 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-11-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219252-003 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-11-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219252-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-11-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219252-002 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-11-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219252-003 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-11-24 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219252-001 | VERAPAMIL HYDROCHLORIDE | 120MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-11-24 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219252-002 | VERAPAMIL HYDROCHLORIDE | 180MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-11-24 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219252-003 | VERAPAMIL HYDROCHLORIDE | 240MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-11-24 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A219252-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219252-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219252-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219252-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219252-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219252-003 | AB | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219252-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219252-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219252-003 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | Zydus Lifesciences Limited | 051392d3-8ec1-450c-8c38-791d4ef1a2db | 2026-04-09 | 219252 ANDA219252 | |
| Verapamil hydrochloride | VERAPAMIL HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | e19ab8d8-dae5-489d-9805-7e7407bea06d | 2026-04-06 | Warnings, Adverse reactions | 219252 ANDA219252 |