Application 072376
- Type
- ANDA
- Sponsor
- QUANTUM PHARMICS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A072376-001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 |
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 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A072376-001 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-03-15 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Lifestar Pharma LLC | fdaf3bd7-c456-40bd-8bc3-2b67eb1846c8 | 2025-08-01 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Mylan Institutional Inc. | 137a953b-3c48-405f-86a6-ff778cb7f5f2 | 2025-07-18 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | 4920401a-cde5-404b-82aa-c3c0e8911065 | 2025-07-17 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Lannett Company, Inc. | f350afed-120b-422d-9e6e-3aaa0f72a5fb | 2025-07-16 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | 207bb11e-6029-4506-92d2-2d8a776b9408 | 2025-05-02 | Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | bc3b0401-df4a-46a2-a29b-3d70e72aa88b | 2025-05-01 | Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | 2a9c2159-e89e-47e4-b91c-ac5560607a2d | 2025-04-12 | Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin hydrochloride | DOXEPIN HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 66c6af99-9909-4b18-a43b-898a1c4a34d7 | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | Doxepin hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin | DOXEPIN HYDROCHLORIDE | Strides Pharma Science Limited | 399866d5-3fa6-46d0-9c62-492d5997bc4f | 2025-03-21 | Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | 3bc72772-22ae-4f29-97ff-4a552b4df6d0 | 2025-01-28 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | 06e027bb-516d-4a1d-b5a0-a66c051eb367 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | direct rx | b56cdaee-6187-c763-e053-2995a90acc3f | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 2bf7d838-6274-4d8a-91cb-b27e1e81d273 | 2025-01-03 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f900bac4-02f2-6bf3-e053-6394a90a2161 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin hydrochloride | DOXEPIN HYDROCHLORIDE | Golden State Medical Supply, Inc. | 00ef7d0b-4bb9-cd5b-e063-6294a90abc35 | 2024-12-24 | Warnings, Adverse reactions | Doxepin hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Amneal Pharmaceuticals NY LLC | 20bfb8af-7933-4e5c-a2b5-010659d9125b | 2024-12-09 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | 19c8ad61-4e4f-4c59-b196-34a4e470459f | 2024-11-13 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | 13da67ec-370c-4647-8440-80fd55f1398e | 2024-11-12 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | eb6954cf-e96b-4e54-961d-6b094384bac9 | 2024-09-18 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 214b6c28-7418-5ebd-e063-6394a90ae833 | 2024-09-04 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |