Application 217633
- Type
- ANDA
- Sponsor
- ALEMBIC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 002 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 003 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | TABLET;ORAL | 90MG | No | No |
| 004 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | TABLET;ORAL | 120MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217633-001 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2025-11-14 | |
| A217633-002 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2025-11-14 | |
| A217633-003 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 90MG | TABLET / ORAL | AB | 2025-11-14 | |
| A217633-004 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2025-11-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217633-001 | AB |
| A217633-002 | AB |
| A217633-003 | AB |
| A217633-004 | 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 | A217633-001 | DILTIAZEM HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2025-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217633-002 | DILTIAZEM HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2025-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217633-003 | DILTIAZEM HYDROCHLORIDE | 90MG | TABLET / ORAL | AB | 2025-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217633-004 | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2025-11-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217633-001 | DILTIAZEM HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2025-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217633-002 | DILTIAZEM HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2025-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217633-003 | DILTIAZEM HYDROCHLORIDE | 90MG | TABLET / ORAL | AB | 2025-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217633-004 | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2025-11-14 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217633-001 | DILTIAZEM HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2025-11-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217633-002 | DILTIAZEM HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2025-11-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217633-003 | DILTIAZEM HYDROCHLORIDE | 90MG | TABLET / ORAL | AB | 2025-11-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217633-004 | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2025-11-14 | 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 | A217633-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217633-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217633-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217633-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217633-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217633-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217633-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217633-004 | AB | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217633-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217633-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217633-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A217633-004 | 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 |
|---|---|---|---|---|---|---|
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Alembic Pharmaceuticals Limited | 74bab197-f719-48c0-ac84-c0cf0087b45a | 2025-11-21 | Warnings, Adverse reactions | 217633 ANDA217633 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | ab38794a-914d-4bcd-9c6d-1578aa10041a | 2025-11-19 | Warnings, Adverse reactions | 217633 ANDA217633 |