Application 040903
- Type
- ANDA
- Sponsor
- LEADING PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 003 | IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040903-001 | IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-10-24 | |
| A040903-002 | IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2012-10-24 | |
| A040903-003 | IMIPRAMINE HYDROCHLORIDE | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2012-10-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040903-001 | AB |
| A040903-002 | AB |
| A040903-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040903-001 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-10-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040903-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2012-10-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040903-003 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2012-10-24 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040903-001 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-10-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040903-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2012-10-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040903-003 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2012-10-24 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040903-001 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-10-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040903-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2012-10-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040903-003 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2012-10-24 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040903-001 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-10-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040903-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2012-10-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040903-003 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2012-10-24 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040903-001 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-10-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040903-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2012-10-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040903-003 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2012-10-24 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040903-001 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-10-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040903-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2012-10-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040903-003 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2012-10-24 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040903-001 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-10-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040903-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2012-10-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040903-003 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2012-10-24 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040903-001 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-10-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040903-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2012-10-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040903-003 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2012-10-24 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040903-001 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-10-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040903-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2012-10-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040903-003 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2012-10-24 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040903-001 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-10-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040903-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2012-10-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040903-003 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2012-10-24 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040903-001 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-10-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040903-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2012-10-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040903-003 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2012-10-24 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040903-001 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-10-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040903-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2012-10-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040903-003 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2012-10-24 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040903-001 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-10-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040903-002 | IMIPRAMINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AB | 2012-10-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040903-003 | IMIPRAMINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | RS | 2012-10-24 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040903-001 | IMIPRAMINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2012-10-24 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040903-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040903-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040903-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040903-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040903-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040903-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040903-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040903-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040903-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040903-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040903-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040903-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040903-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040903-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040903-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040903-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040903-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040903-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040903-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040903-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040903-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040903-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040903-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040903-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040903-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040903-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040903-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040903-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040903-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040903-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040903-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040903-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040903-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040903-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040903-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040903-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040903-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040903-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040903-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040903-001 | AB | 1 | 1e350fbaab3a… |
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 |
|---|---|---|---|---|---|---|
| Imipramine Hydrochloride | IMIPRAMINE HYDROCHLORIDE | Leading Pharma, LLC | 490263ce-b4d2-428a-87da-fcd07f85499a | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 040903 ANDA040903 69315-135 69315-134 69315-133 |
| Imipramine Hydrochloride | IMIPRAMINE HYDROCHLORIDE | A-S Medication Solutions | d9dbcebe-9aba-4a93-a7b7-48d29e07d3c4 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 040903 ANDA040903 50090-3148 |
| Imipramine Hydrochloride | IMIPRAMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7091ff32-55b9-48fd-a86d-c502af57473f | 2026-03-27 | Boxed warning, Warnings, Adverse reactions | 040903 ANDA040903 |
| Imipramine Hydrochloride | IMIPRAMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 649837df-147f-436c-9553-32ffecf4c6f1 | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | 040903 ANDA040903 |
| Imipramine Hydrochloride | IMIPRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | bcd3b62a-88d4-49eb-b0aa-71e28cf40919 | 2026-03-16 | Boxed warning, Warnings, Adverse reactions | 040903 ANDA040903 |
| Imipramine Hydrochloride | IMIPRAMINE HYDROCHLORIDE | REMEDYREPACK INC. | db007ac0-020e-4962-8903-7497ab96a74e | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | 040903 ANDA040903 70518-1588 |
| Imipramine Hydrochloride | IMIPRAMINE HYDROCHLORIDE | Coupler LLC | 48e8b819-a9a0-aa5a-e063-6394a90ad9c2 | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | 040903 ANDA040903 |
| Imipramine Hydrochloride | IMIPRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | 20af582f-08ba-4281-a2df-0bcf68c58594 | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | 040903 ANDA040903 |
| Imipramine hydrochloride | IMIPRAMINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f887062a-7c82-664f-e053-6294a90a2773 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 040903 ANDA040903 |
| Imipramine Hydrochloride | IMIPRAMINE HYDROCHLORIDE | Proficient Rx LP | 3f90b8dd-7234-4428-b896-943d052dd05f | 2023-06-01 | Boxed warning, Warnings, Adverse reactions | 040903 ANDA040903 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42291-345 | Imipramine Hydrochloride | Imipramine Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-345 | Imipramine Hydrochloride | Imipramine Hydrochloride | AvKARE | ANDA | Current |
| 42291-346 | Imipramine Hydrochloride | Imipramine Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-346 | Imipramine Hydrochloride | Imipramine Hydrochloride | AvKARE | ANDA | Current |
| 42291-347 | Imipramine Hydrochloride | Imipramine Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-347 | Imipramine Hydrochloride | Imipramine Hydrochloride | AvKARE | ANDA | Current |
| 50090-3148 | Imipramine Hydrochloride | Imipramine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3148 | Imipramine Hydrochloride | Imipramine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 55700-709 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-709 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-709 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-709 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-709 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-709 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LL | ANDA | Current |
| 55700-710 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-710 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-710 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-710 | Imipramine Hydrochloride | Imipramine Hydrochloride | Quality Care Products, LL | ANDA | Current |
| 64125-133 | Imipramine Hydrochloride | Imipramine Hydrochloride | Excellium Pharmaceutical, Inc | ANDA | Current |
| 64125-134 | Imipramine Hydrochloride | Imipramine Hydrochloride | Excellium Pharmaceutical, Inc | ANDA | Current |
| 64125-135 | Imipramine Hydrochloride | Imipramine Hydrochloride | Excellium Pharmaceutical, Inc | ANDA | Current |
| 69315-133 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-133 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-133 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-133 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-134 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-134 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-134 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-134 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-135 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-135 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-135 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 69315-135 | Imipramine Hydrochloride | Imipramine Hydrochloride | Leading Pharma, LLC | ANDA | Current |
| 70518-0006 | Imipramine Hydrochloride | Imipramine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0006 | Imipramine Hydrochloride | Imipramine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0127 | Imipramine Hydrochloride | Imipramine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1588 | Imipramine Hydrochloride | Imipramine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1588 | Imipramine Hydrochloride | Imipramine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1588 | Imipramine Hydrochloride | Imipramine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1588 | Imipramine Hydrochloride | Imipramine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 38902 | ORIG | 2013-10-04 |