Application 072375
- Type
- ANDA
- Sponsor
- QUANTUM PHARMICS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 100MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A072375-001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A072375-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1989-03-15 | cb3db0bc1861… |
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 | Novadoz Pharmaceuticals LLC | 2b1f0144-65d8-451f-8054-6be1675f102c | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin hydrochloride | DOXEPIN HYDROCHLORIDE | Novadoz Pharmaceuticals LLC | 96086fd8-8fa3-4a2b-ac12-fe1a3ad4f384 | 2026-07-23 | Warnings, Adverse reactions | Doxepin hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | A-S Medication Solutions | 78cf65ff-43f9-4f5e-95dd-864acc89c02a | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Proficient Rx LP | d7a6768a-927b-4f51-858d-1ddfa9d5c5d3 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | 0d981fbd-3605-417b-91d7-799b21c1a9e3 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin hydrochloride | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | 46be666a-fb9f-42a5-a55c-ea15fd5538c9 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | Doxepin hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin hydrochloride | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | 4ecd3b43-b5f1-4cf4-af36-eb214c1a3c60 | 2026-06-18 | Boxed warning, Warnings, Adverse reactions | Doxepin hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin hydrochloride | DOXEPIN HYDROCHLORIDE | Coupler LLC | 54616c93-2325-4719-e063-6394a90a3910 | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | Doxepin hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin hydrochloride | DOXEPIN HYDROCHLORIDE | Coupler LLC | 538643c0-b8d1-d71f-e063-6294a90a7734 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | Doxepin hydrochloride DOXEPIN HYDROCHLORIDE |
| Silenor | DOXEPIN HYDROCHLORIDE | Currax Pharmaceuticals LLC | 1bec1223-5239-4eb6-a9e8-62444106d2c0 | 2026-04-21 | Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | c577af7c-2405-4454-a169-5b6a4fa0c7bf | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Safecor Health, LLC | a2297f75-c498-419b-aa29-057271313a7f | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 1ede17e6-19e9-455c-ad16-8029a590735c | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | d2a91b99-513d-4894-ad6d-02d2028a2290 | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | e6a4cb10-1928-4abe-8797-404c9ddc37dd | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Leading Pharma, LLC | d5df4beb-8048-4b83-aa59-19876437001d | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 1496dfc1-de50-471c-be87-1f1e2b70ab5a | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | A-S Medication Solutions | e0460c02-3dae-4b19-845c-2ffcfb587f6d | 2025-12-16 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Redpharm Drug | 37451a61-ccb1-57b3-e063-6294a90a2592 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Chartwell RX, LLC | 33a15c3f-bec0-4703-a4e9-f8f78f8b5fd3 | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |