Application 219253
- Type
- ANDA
- Sponsor
- ZYDUS LIFESCIENCES
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 |
|---|---|---|---|---|---|---|---|
| A219253-001 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2025-08-08 | |
| A219253-002 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2025-08-08 | |
| A219253-003 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 90MG | TABLET / ORAL | AB | 2025-08-08 | |
| A219253-004 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2025-08-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219253-001 | AB |
| A219253-002 | AB |
| A219253-003 | AB |
| A219253-004 | 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 | A219253-001 | DILTIAZEM HYDROCHLORIDE | 30MG | TABLET / ORAL | 2025-08-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A219253-002 | DILTIAZEM HYDROCHLORIDE | 60MG | TABLET / ORAL | 2025-08-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A219253-003 | DILTIAZEM HYDROCHLORIDE | 90MG | TABLET / ORAL | 2025-08-08 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A219253-004 | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET / ORAL | 2025-08-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219253-001 | DILTIAZEM HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2025-08-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219253-002 | DILTIAZEM HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2025-08-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219253-003 | DILTIAZEM HYDROCHLORIDE | 90MG | TABLET / ORAL | AB | 2025-08-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219253-004 | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2025-08-08 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219253-001 | DILTIAZEM HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2025-08-08 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219253-002 | DILTIAZEM HYDROCHLORIDE | 60MG | TABLET / ORAL | AB | 2025-08-08 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219253-003 | DILTIAZEM HYDROCHLORIDE | 90MG | TABLET / ORAL | AB | 2025-08-08 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219253-004 | DILTIAZEM HYDROCHLORIDE | 120MG | TABLET / ORAL | AB | 2025-08-08 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219253-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219253-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219253-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219253-004 | AB | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219253-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219253-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219253-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219253-004 | 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 | Zydus Lifesciences Limited | 8329d0ac-d68c-48d2-9cbc-e1a1b60192d9 | 2026-05-01 | 219253 ANDA219253 | |
| Diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Viona Pharmaceuticals Inc | 43cffe12-304a-4e15-9512-94f812188f1a | 2025-05-05 | Warnings, Adverse reactions | 219253 ANDA219253 |