Application 205231
- Type
- ANDA
- Sponsor
- TWI PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 120MG | No | No |
| 002 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 180MG | No | No |
| 003 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 240MG | No | No |
| 004 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 300MG | No | No |
| 005 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 360MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205231-001 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | |
| A205231-002 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | |
| A205231-003 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | |
| A205231-004 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | |
| A205231-005 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205231-001 | AB3 |
| A205231-002 | AB3 |
| A205231-003 | AB3 |
| A205231-004 | AB3 |
| A205231-005 | AB3 |
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 | A205231-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205231-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205231-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205231-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205231-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205231-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205231-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205231-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205231-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205231-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205231-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205231-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205231-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205231-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205231-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205231-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205231-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205231-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205231-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205231-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205231-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205231-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205231-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205231-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205231-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205231-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205231-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205231-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205231-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205231-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205231-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205231-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205231-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205231-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205231-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205231-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205231-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205231-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205231-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205231-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2018-08-30 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A205231-001 | AB3 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205231-002 | AB3 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205231-003 | AB3 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205231-004 | AB3 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205231-005 | AB3 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A205231-001 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205231-002 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205231-003 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205231-004 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205231-005 | AB3 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205231-001 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205231-002 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205231-003 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205231-004 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205231-005 | AB3 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205231-001 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205231-002 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205231-003 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205231-004 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205231-005 | AB3 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205231-001 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205231-002 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205231-003 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205231-004 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205231-005 | AB3 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205231-001 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205231-002 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205231-003 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205231-004 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205231-005 | AB3 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205231-001 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205231-002 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205231-003 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205231-004 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205231-005 | AB3 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205231-001 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205231-002 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205231-003 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205231-004 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205231-005 | AB3 | 1 | 2680178bc6a6… |
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 | Major Pharmaceuticals | e7476adc-a940-4e76-a1dd-c418de493bc0 | 2026-07-14 | Warnings, Adverse reactions | 205231 ANDA205231 0904-7220 0904-7218 0904-7219 0904-7217 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | A-S Medication Solutions | 465dbab3-f201-4441-8f55-92a843b5134f | 2026-06-19 | Warnings, Adverse reactions | 205231 ANDA205231 50090-5466 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Golden State Medical Supply, Inc. | c9f17187-e958-106b-e053-2a95a90a54d8 | 2026-06-16 | Warnings, Adverse reactions | 205231 ANDA205231 51407-473 51407-476 51407-474 51407-475 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Cardinal Health 107, LLC | bdb9e7cf-bfbb-48b4-a8be-9038820d8279 | 2026-04-23 | Warnings, Adverse reactions | 205231 ANDA205231 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Upsher-Smith Laboratories, LLC | bb32d681-9a83-431e-9984-a5cee2c94852 | 2026-04-01 | Warnings, Adverse reactions | 205231 ANDA205231 24979-027 24979-029 24979-026 24979-028 24979-030 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | A-S Medication Solutions | 839af3af-4040-4cf4-8d4a-881a053514cc | 2026-03-17 | Warnings, Adverse reactions | 205231 ANDA205231 50090-5452 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 22e653e5-4122-4d7d-b9ad-0bdc1390fb40 | 2025-10-20 | Adverse reactions | 205231 ANDA205231 71335-2129 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | c8809dc9-b99b-4d30-a7da-0bc21aa90f9c | 2025-10-02 | Warnings, Adverse reactions | 205231 ANDA205231 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | A-S Medication Solutions | f317de31-495c-4268-8171-89534bf1dd36 | 2024-05-07 | Warnings, Adverse reactions | 205231 ANDA205231 50090-5416 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-7217 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7218 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7219 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7220 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 24979-026 | Diltiazem Hydrochloride | Diltiazem hydrochloride | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-027 | Diltiazem Hydrochloride | Diltiazem hydrochloride | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-028 | Diltiazem Hydrochloride | Diltiazem hydrochloride | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-029 | Diltiazem Hydrochloride | Diltiazem hydrochloride | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 24979-030 | Diltiazem Hydrochloride | Diltiazem hydrochloride | TWi Pharmaceuticals, Inc. | ANDA | Current |
| 50090-5416 | Diltiazem Hydrochloride | Diltiazem hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5416 | Diltiazem Hydrochloride | Diltiazem hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5452 | Diltiazem Hydrochloride | Diltiazem hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5452 | Diltiazem Hydrochloride | Diltiazem hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5466 | Diltiazem Hydrochloride | Diltiazem hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5466 | Diltiazem Hydrochloride | Diltiazem hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5466 | Diltiazem Hydrochloride | Diltiazem hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51407-473 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-473 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-474 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-474 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-475 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-475 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-476 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-476 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 70518-2506 | Diltiazem Hydrochloride | Diltiazem hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2506 | Diltiazem Hydrochloride | Diltiazem hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2506 | Diltiazem Hydrochloride | Diltiazem hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2506 | Diltiazem Hydrochloride | Diltiazem hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2789 | Diltiazem Hydrochloride | Diltiazem hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2789 | Diltiazem Hydrochloride | Diltiazem hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3337 | Diltiazem Hydrochloride | Diltiazem hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70934-564 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-565 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71335-2129 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Bryant Ranch Prepack | ANDA | Current |