Application 207482
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE | No | No |
| 002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 25MG BASE | No | No |
| 003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE | No | No |
| 004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 75MG BASE | No | No |
| 005 | 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 |
|---|---|---|---|---|---|---|---|
| A207482-001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | |
| A207482-002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | |
| A207482-003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | |
| A207482-004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | |
| A207482-005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-06-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207482-001 | AB |
| A207482-002 | AB |
| A207482-003 | AB |
| A207482-004 | AB |
| A207482-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A207482-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207482-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207482-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207482-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A207482-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A207482-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207482-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207482-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207482-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207482-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207482-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207482-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207482-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207482-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207482-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207482-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207482-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207482-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207482-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207482-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207482-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207482-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207482-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207482-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207482-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207482-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207482-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207482-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207482-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207482-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207482-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207482-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207482-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207482-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207482-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207482-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207482-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207482-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207482-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207482-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2017-06-28 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-12-22 03:56 UTC | 2020-12 | A207482-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A207482-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A207482-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A207482-004 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A207482-005 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A207482-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A207482-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A207482-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A207482-004 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A207482-005 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A207482-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A207482-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A207482-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A207482-004 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A207482-005 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A207482-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A207482-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A207482-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A207482-004 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A207482-005 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A207482-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A207482-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A207482-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A207482-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A207482-005 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207482-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207482-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207482-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207482-004 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207482-005 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A207482-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A207482-002 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A207482-003 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A207482-004 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A207482-005 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A207482-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A207482-002 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A207482-003 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A207482-004 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A207482-005 | AB | 1 | ea1830bbd6c7… |
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 | A-S Medication Solutions | 78cf65ff-43f9-4f5e-95dd-864acc89c02a | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 207482 ANDA207482 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Redpharm Drug | 37451a61-ccb1-57b3-e063-6294a90a2592 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | 207482 ANDA207482 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Major Pharmaceuticals | df3b6be0-6a64-4174-b351-dab2061f290e | 2025-09-10 | Boxed warning, Warnings, Adverse reactions | 207482 ANDA207482 0904-7055 0904-7052 0904-7053 0904-7054 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | 3bc72772-22ae-4f29-97ff-4a552b4df6d0 | 2025-01-28 | Boxed warning, Warnings, Adverse reactions | 207482 ANDA207482 71335-0072 |
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 |
|---|---|---|---|---|---|
| 0904-7052 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7052 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7052 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7052 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7052 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7053 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7053 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7053 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7053 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7054 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7054 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7054 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7055 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7055 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7055 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 61919-863 | DOXEPIN HCL | DOXEPIN HCL | Direct_Rx | ANDA | Current |
| 69238-1166 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1166 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1166 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1166 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1166 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1170 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1170 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1170 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1170 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1170 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1171 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1171 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1171 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1171 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1171 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1172 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1172 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1172 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1172 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1172 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1173 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1173 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1173 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1173 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1173 | Doxepin Hydrochloride | Doxepin Hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 70518-1380 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1380 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1412 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1412 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-0072 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0072 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0072 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0780 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0780 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48880 | ORIG | 2017-06-30 |