Application 211603
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 |
|---|---|---|---|---|---|---|---|
| A211603-001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | |
| A211603-002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | |
| A211603-003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | |
| A211603-004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | |
| A211603-005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211603-001 | AB |
| A211603-002 | AB |
| A211603-003 | AB |
| A211603-004 | AB |
| A211603-005 | 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 | A211603-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211603-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211603-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211603-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211603-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A211603-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211603-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211603-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211603-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211603-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 2019-03-27 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211603-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211603-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211603-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211603-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211603-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A211603-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211603-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211603-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211603-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211603-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211603-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211603-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211603-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211603-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211603-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211603-005 | AB | 1 | 03ed91905a0d… |
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 | PD-Rx Pharmaceuticals, Inc. | 1496dfc1-de50-471c-be87-1f1e2b70ab5a | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 211603 ANDA211603 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Aurobindo Pharma Limited | f3c242dd-426e-4c69-8f21-2645361d5f27 | 2025-09-01 | Boxed warning, Warnings, Adverse reactions | 211603 ANDA211603 59651-176 59651-177 59651-174 59651-173 59651-175 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 2bf7d838-6274-4d8a-91cb-b27e1e81d273 | 2025-01-03 | Boxed warning, Warnings, Adverse reactions | 211603 ANDA211603 72789-220 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 9ee26b24-7121-3107-e053-2995a90ac61c | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 211603 ANDA211603 68071-5179 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Proficient Rx LP | 6ce7fde2-2d47-4238-9beb-555d352f4657 | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | 211603 ANDA211603 71205-610 |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Proficient Rx LP | e98f371e-f7fe-4c8f-9491-6eb4c53d43ad | 2021-02-01 | Boxed warning, Warnings, Adverse reactions | 211603 ANDA211603 71205-534 |
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 |
|---|---|---|---|---|---|
| 45865-103 | Doxepin Hydrochloride | Doxepin Hydrochloride | Medsource Pharmaceuticals | ANDA | Current |
| 55700-768 | Doxepin Hydrochloride | Doxepin Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-768 | Doxepin Hydrochloride | Doxepin Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-783 | Doxepin Hydrochloride | Doxepin Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-783 | Doxepin Hydrochloride | Doxepin Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-831 | Doxepin Hydrochloride | Doxepin Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 59651-173 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-173 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-173 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-174 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-174 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-174 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-175 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-175 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-175 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-176 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-176 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-176 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-177 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-177 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-177 | Doxepin Hydrochloride | Doxepin Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 68071-5179 | Doxepin Hydrochloride | Doxepin Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5179 | Doxepin Hydrochloride | Doxepin Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5260 | Doxepin Hydrochloride | Doxepin Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5260 | Doxepin Hydrochloride | Doxepin Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7731 | Doxepin Hydrochloride | Doxepin Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7731 | Doxepin Hydrochloride | Doxepin Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-2274 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2274 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2274 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2371 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2371 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2371 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2401 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2401 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2401 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2468 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2468 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2468 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2519 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2519 | Doxepin Hydrochloride | Doxepin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71205-534 | Doxepin Hydrochloride | Doxepin Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-610 | Doxepin Hydrochloride | Doxepin Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-610 | Doxepin Hydrochloride | Doxepin Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71335-1450 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1450 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1665 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1665 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 72789-220 | Doxepin Hydrochloride | Doxepin Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-220 | Doxepin Hydrochloride | Doxepin Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-220 | Doxepin Hydrochloride | Doxepin Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |