Application 208783
- Type
- ANDA
- Sponsor
- NOVAST LABS
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 |
|---|---|---|---|---|---|---|---|
| A208783-001 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | |
| A208783-002 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | |
| A208783-003 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | |
| A208783-004 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | |
| A208783-005 | DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208783-001 | AB3 |
| A208783-002 | AB3 |
| A208783-003 | AB3 |
| A208783-004 | AB3 |
| A208783-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A208783-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208783-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208783-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208783-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208783-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-001 | DILTIAZEM HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-002 | DILTIAZEM HYDROCHLORIDE | 180MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-003 | DILTIAZEM HYDROCHLORIDE | 240MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-004 | DILTIAZEM HYDROCHLORIDE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-005 | DILTIAZEM HYDROCHLORIDE | 360MG | CAPSULE, EXTENDED RELEASE / ORAL | AB3 | 2019-06-14 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A208783-001 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208783-002 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208783-003 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208783-004 | AB3 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208783-005 | AB3 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-001 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-002 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-003 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-004 | AB3 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208783-005 | AB3 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-001 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-002 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-003 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-004 | AB3 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208783-005 | AB3 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-001 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-002 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-003 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-004 | AB3 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208783-005 | AB3 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-001 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-002 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-003 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-004 | AB3 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208783-005 | AB3 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-001 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-002 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-003 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-004 | AB3 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208783-005 | AB3 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-001 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-002 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-003 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-004 | AB3 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208783-005 | AB3 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-001 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-002 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-003 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-004 | AB3 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208783-005 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | ec928ee5-0809-4ba5-82ca-ecfed99ebb5a | 2026-07-21 | Warnings, Adverse reactions | 208783 ANDA208783 71335-1776 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | REMEDYREPACK INC. | 5e935265-d0fc-4223-835f-72426eeea6c4 | 2026-04-10 | Warnings, Adverse reactions | 208783 ANDA208783 70518-3484 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 3d594530-885f-45c7-b8a5-fd7e503ff83f | 2026-04-06 | Warnings, Adverse reactions | 208783 ANDA208783 68788-7870 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | a469b24a-fbec-4a2d-8b4c-b62c2b2c66f6 | 2026-02-17 | Warnings, Adverse reactions | 208783 ANDA208783 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | e6d9397c-f8a2-42d6-88ca-55060b1d073a | 2025-08-26 | Warnings, Adverse reactions | 208783 ANDA208783 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 9041cc05-29d2-41ca-a368-e953bf3443b5 | 2025-08-25 | Warnings, Adverse reactions | 208783 ANDA208783 71335-2089 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 0089fc7a-a7aa-4873-b699-39a1b21616ca | 2025-08-20 | Warnings, Adverse reactions | 208783 ANDA208783 71335-1897 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Ingenus Pharmaceuticals, LLC | 355f560a-8ebb-4661-ad74-2a22f707d7f8 | 2025-06-17 | Warnings, Adverse reactions | 208783 ANDA208783 50742-248 50742-251 50742-249 50742-250 50742-252 |
| Diltiazem HCL ER | DILTIAZEM HCL ER | Direct_Rx | f1ea85b2-ecd2-5867-e053-2a95a90a24dc | 2025-01-22 | Warnings, Adverse reactions | 208783 ANDA208783 72189-409 |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 70f167a1-ec7f-4969-b446-166af3e52c05 | 2024-09-13 | Warnings, Adverse reactions | 208783 ANDA208783 0615-8380 0615-8381 0615-8379 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-8379 | diltiazem hydrochloride | diltiazem hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8380 | diltiazem hydrochloride | diltiazem hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8381 | diltiazem hydrochloride | diltiazem hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 50742-248 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-248 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-248 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-248 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-249 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-249 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-249 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-249 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-250 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-250 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-250 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-250 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-251 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-251 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-251 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-251 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-252 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-252 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-252 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 50742-252 | diltiazem hydrochloride | diltiazem hydrochloride | Ingenus Pharmaceuticals, LLC | ANDA | Current |
| 68788-7870 | diltiazem hydrochloride | diltiazem hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7870 | diltiazem hydrochloride | diltiazem hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-3484 | diltiazem hydrochloride | diltiazem hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-1776 | diltiazem hydrochloride | diltiazem hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1776 | diltiazem hydrochloride | diltiazem hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1897 | diltiazem hydrochloride | diltiazem hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-2089 | diltiazem hydrochloride | diltiazem hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 72189-409 | Cardizem | Diltiazem HCL ER | Direct_Rx | ANDA | Current |