Application 071422
- Type
- ANDA
- Sponsor
- PAR PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 100MG BASE | No | No |
| 002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE | No | No |
| 003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 25MG BASE | No | No |
| 004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE | No | No |
| 005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 75MG BASE | No | No |
| 006 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A071422-001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1987-11-09 | ||
| A071422-002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 1987-11-09 | ||
| A071422-003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 1987-11-09 | ||
| A071422-004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 1987-11-09 | ||
| A071422-005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 1987-11-09 | ||
| A071422-006 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1987-11-09 |
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 | A071422-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1987-11-09 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A071422-002 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 1987-11-09 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A071422-003 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 1987-11-09 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A071422-004 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 1987-11-09 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A071422-005 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 1987-11-09 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A071422-006 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1987-11-09 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A071422-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1987-11-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A071422-002 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 1987-11-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A071422-003 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 1987-11-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A071422-004 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 1987-11-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A071422-005 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 1987-11-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A071422-006 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1987-11-09 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A071422-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1987-11-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A071422-002 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 1987-11-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A071422-003 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 1987-11-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A071422-004 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 1987-11-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A071422-005 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 1987-11-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A071422-006 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RS | 1987-11-09 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071422-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1987-11-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071422-002 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 1987-11-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071422-003 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 1987-11-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071422-004 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 1987-11-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071422-005 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 1987-11-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071422-006 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RS | 1987-11-09 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A071422-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1987-11-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A071422-002 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 1987-11-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A071422-003 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 1987-11-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A071422-004 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 1987-11-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A071422-005 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 1987-11-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A071422-006 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RS | 1987-11-09 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071422-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1987-11-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071422-002 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 1987-11-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071422-003 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 1987-11-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071422-004 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 1987-11-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071422-005 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 1987-11-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071422-006 | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RS | 1987-11-09 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071422-001 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 1987-11-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071422-002 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 1987-11-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071422-003 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 1987-11-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071422-004 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 1987-11-09 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A071422-005 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A071422-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A071422-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A071422-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A071422-004 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A071422-005 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071422-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071422-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071422-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071422-004 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071422-005 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A071422-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A071422-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A071422-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A071422-004 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A071422-005 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A071422-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A071422-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A071422-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A071422-004 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A071422-005 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A071422-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A071422-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A071422-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A071422-004 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A071422-005 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A071422-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A071422-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A071422-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A071422-004 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A071422-005 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A071422-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A071422-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A071422-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A071422-004 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A071422-005 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A071422-006 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A071422-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071422-006 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A071422-006 | AB | 1 | 1c564ffb4f44… |
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 | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | 2a9c2159-e89e-47e4-b91c-ac5560607a2d | 2026-09-04 | Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | 21dc77be-23af-4a1f-b189-dfee8ae2f894 | 2026-09-03 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE |
| Doxepin hydrochloride | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | 7a8c56ab-5dd1-4e1a-b26a-3af45b961dd0 | 2026-09-03 | Warnings, Adverse reactions | Doxepin hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | 670edc2b-7914-479e-b4dd-d5c86706a631 | 2026-09-01 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | d29a8c70-cf1c-4bf8-bb87-1c80babce64e | 2026-09-01 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | 90d9041f-985b-470b-8cbb-f05dbfc770c9 | 2026-09-01 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | 5ee0f8e6-df05-4166-a614-77e124db95ae | 2026-08-31 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | 99ff6e3e-8c12-4393-96ae-206d86d26947 | 2026-08-28 | Boxed warning, Warnings, Adverse reactions | Doxepin Hydrochloride DOXEPIN HYDROCHLORIDE |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | REMEDYREPACK INC. | 0ae2e882-2570-404b-8529-0414eee5f95a | 2026-08-24 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE DOXEPIN HYDROCHLORIDE |
| doxepin hydrochloride | DOXEPIN HYDROCHLORIDE | Golden State Medical Supply, Inc. | 57efdc34-d619-e413-e063-6394a90a0e04 | 2026-07-31 | Warnings, Adverse reactions | doxepin hydrochloride DOXEPIN HYDROCHLORIDE |
| 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. | 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 |
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 |
|---|---|---|---|---|---|
| 0904-6970 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6970 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6971 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6971 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6972 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6972 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6973 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6973 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6973 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6973 | Doxepin Hydrochloride | Doxepin Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 45865-968 | Doxepin Hydrochloride | Doxepin Hydrochloride | medsource pharmaceuticals | ANDA | Current |
| 49884-217 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-217 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-217 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-217 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-218 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-218 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-218 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-218 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-219 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-219 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-219 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-219 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-220 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-220 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-220 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-221 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-221 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-221 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-221 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-221 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-222 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-222 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-222 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 49884-222 | Doxepin Hydrochloride | Doxepin Hydrochloride | Par Pharmaceutical, Inc. | ANDA | Current |
| 63629-2180 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2180 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2180 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2181 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2181 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2181 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2182 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2182 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2182 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7852 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0642 | Doxepin Hydrochloride | Doxepin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |