Application 075116
- Type
- ANDA
- Sponsor
- VALEANT PHARMS NORTH
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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075116-001 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | |
| A075116-002 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | |
| A075116-003 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | |
| A075116-004 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075116-001 | AB3 |
| A075116-002 | AB3 |
| A075116-003 | AB3 |
| A075116-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075116-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075116-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075116-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075116-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075116-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075116-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075116-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075116-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075116-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075116-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075116-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075116-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075116-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075116-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075116-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075116-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075116-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075116-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075116-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075116-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075116-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075116-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075116-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075116-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075116-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075116-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075116-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075116-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075116-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075116-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075116-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075116-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075116-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075116-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075116-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075116-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075116-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075116-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075116-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075116-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-23 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075116-001 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075116-002 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075116-003 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075116-004 | AB3 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075116-001 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075116-002 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075116-003 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075116-004 | AB3 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075116-001 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075116-002 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075116-003 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075116-004 | AB3 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075116-001 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075116-002 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075116-003 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075116-004 | AB3 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075116-001 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075116-002 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075116-003 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075116-004 | AB3 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075116-001 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075116-002 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075116-003 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075116-004 | AB3 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075116-001 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075116-002 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075116-003 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075116-004 | AB3 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075116-001 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075116-002 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075116-003 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075116-004 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075116-001 | AB3 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075116-002 | AB3 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075116-003 | AB3 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075116-004 | AB3 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075116-001 | AB3 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075116-002 | AB3 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075116-003 | AB3 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075116-004 | AB3 | 1 | d06236e962d9… |
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 | A-S Medication Solutions | 090aa3a9-910e-4f96-b748-783109aa96e6 | 2025-12-12 | Warnings, Adverse reactions | 075116 ANDA075116 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | c1ef9e90-6ff0-4ee5-86a3-1efee9c36789 | 2025-09-16 | Warnings, Adverse reactions | 075116 ANDA075116 71335-0634 71335-0867 71335-1389 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | OCEANSIDE PHARMACEUTICALS | 43892b97-449d-45bc-bb09-29d47c655d65 | 2025-07-31 | Warnings, Adverse reactions | 075116 ANDA075116 68682-993 68682-998 68682-997 68682-994 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 54b0b11d-adc0-4afb-e054-00144ff88e88 | 2024-07-17 | Warnings, Adverse reactions | 075116 ANDA075116 68071-4005 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 7cdb473a-e6d5-48e8-e053-2a91aa0aaeb7 | 2024-06-12 | Warnings, Adverse reactions | 075116 ANDA075116 68071-4664 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 609e97e5-ebc7-4268-84ea-f279284c89e2 | 2020-01-19 | Warnings, Adverse reactions | 075116 ANDA075116 71335-0643 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-8127 | Diltiazem Hydrochloride | Diltiazem hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8127 | Diltiazem Hydrochloride | Diltiazem hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8128 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8128 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8129 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8129 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 33261-829 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 50090-1576 | Diltiazem Hydrochloride | Diltiazem hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3062 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3062 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 63629-3564 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 68071-4005 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4005 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4155 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4155 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4371 | Diltiazem Hydrochloride | Diltiazem hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4371 | Diltiazem Hydrochloride | Diltiazem hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4664 | Diltiazem Hydrochloride | Diltiazem hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4664 | Diltiazem Hydrochloride | Diltiazem hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68682-993 | Diltiazem Hydrochloride | Diltiazem hydrochloride | OCEANSIDE PHARMACEUTICALS | ANDA | Current |
| 68682-993 | Diltiazem Hydrochloride | Diltiazem hydrochloride | OCEANSIDE PHARMACEUTICALS | ANDA | Current |
| 68682-994 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | OCEANSIDE PHARMACEUTICALS | ANDA | Current |
| 68682-994 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | OCEANSIDE PHARMACEUTICALS | ANDA | Current |
| 68682-997 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | OCEANSIDE PHARMACEUTICALS | ANDA | Current |
| 68682-997 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | OCEANSIDE PHARMACEUTICALS | ANDA | Current |
| 68682-998 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | OCEANSIDE PHARMACEUTICALS | ANDA | Current |
| 68682-998 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | OCEANSIDE PHARMACEUTICALS | ANDA | Current |
| 70518-2088 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-0634 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0634 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0643 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0643 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0867 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0867 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1389 | Diltiazem Hydrochloride | Diltiazem hydrochloride | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30761 | ORIG | 1999-12-23 |