Application 074984
- Type
- ANDA
- Sponsor
- PAR PHARM
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 |
|---|---|---|---|---|---|---|---|
| A074984-001 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | |
| A074984-002 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | |
| A074984-003 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | |
| A074984-004 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A074984-001 | AB3 |
| A074984-002 | AB3 |
| A074984-003 | AB3 |
| A074984-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074984-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074984-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074984-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074984-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 1999-12-20 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A074984-001 | AB3 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A074984-002 | AB3 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A074984-003 | AB3 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A074984-004 | AB3 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A074984-001 | AB3 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A074984-002 | AB3 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A074984-003 | AB3 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A074984-004 | AB3 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A074984-001 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074984-002 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074984-003 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A074984-004 | AB3 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074984-001 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074984-002 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074984-003 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074984-004 | AB3 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A074984-001 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074984-002 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074984-003 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A074984-004 | AB3 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074984-001 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074984-002 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074984-003 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074984-004 | AB3 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074984-001 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074984-002 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074984-003 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074984-004 | AB3 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074984-001 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074984-002 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074984-003 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074984-004 | AB3 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074984-001 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074984-002 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074984-003 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074984-004 | AB3 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074984-001 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074984-002 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074984-003 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074984-004 | AB3 | 1 | 5bbf6a4d5a75… |
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60687-228 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-228 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-228 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-228 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-228 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-228 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-228 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | American Health Packaging | ANDA | Current |
| 63629-2153 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2153 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2154 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2154 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2155 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2155 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2156 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2156 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2157 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2157 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2158 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2158 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2159 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2159 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2160 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2160 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8232 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63739-014 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-014 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | McKesson Corporation | ANDA | Current |
| 63739-014 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-014 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-015 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-015 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | McKesson Corporation | ANDA | Current |
| 63739-015 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-015 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-016 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-016 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | McKesson Corporation | ANDA | Current |
| 63739-016 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-016 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-284 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | McKesson Corporation | ANDA | Current |
| 63739-284 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-285 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | McKesson Corporation | ANDA | Current |
| 63739-285 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 66336-669 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Dispensing Solutions, Inc. | ANDA | Current |
| 68071-3076 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3076 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3076 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3079 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3214 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceutical, Inc. | ANDA | Current |
| 68071-3214 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceutical, Inc. | ANDA | Current |
| 68071-3214 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceutical, Inc. | ANDA | Current |
| 68071-3264 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceutical, Inc. | ANDA | Current |
| 68071-3264 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceutical, Inc. | ANDA | Current |
| 68071-3264 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | NuCare Pharmaceutical, Inc. | ANDA | Current |
| 68151-1457 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Carilion Materials Management | ANDA | Current |
| 68258-6024 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Dispensing Solutions, Inc. | ANDA | Current |
| 68258-6046 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Dispensing Solutions, Inc. | ANDA | Current |
| 68788-7237 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Preferred Pharmaceutials Inc. | ANDA | Current |
| 68788-7237 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Preferred Pharmaceutials Inc. | ANDA | Current |
| 68788-7237 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Preferred Pharmaceutials Inc. | ANDA | Current |
| 68788-7237 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Preferred Pharmaceutials Inc. | ANDA | Current |
| 70518-1017 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1017 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1017 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1017 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1017 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1017 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1062 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1062 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1062 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2237 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3299 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-0009 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0009 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0009 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0745 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0745 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1043 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1043 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1043 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1063 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1063 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1223 | Diltiazem Hydrochloride | Diltiazem Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30729 | ORIG | 1999-12-20 |