Application 212997
- Type
- ANDA
- Sponsor
- LANNETT CO INC
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 |
|---|---|---|---|---|---|---|---|
| A212997-001 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2020-07-24 | ||
| A212997-002 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2020-07-24 | ||
| A212997-003 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2020-07-24 | ||
| A212997-004 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2020-07-24 | ||
| A212997-005 | DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 2020-07-24 |
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 | A212997-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2020-07-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212997-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2020-07-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212997-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2020-07-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212997-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2020-07-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A212997-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 2020-07-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212997-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2020-07-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212997-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2020-07-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212997-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2020-07-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212997-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2020-07-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A212997-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 2020-07-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212997-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2020-07-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212997-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2020-07-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212997-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2020-07-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212997-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2020-07-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212997-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 2020-07-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212997-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2020-07-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212997-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2020-07-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212997-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2020-07-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212997-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2020-07-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A212997-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 2020-07-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212997-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2020-07-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212997-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2020-07-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212997-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2020-07-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212997-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2020-07-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212997-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 2020-07-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212997-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2020-07-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212997-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2020-07-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212997-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2020-07-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212997-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2020-07-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212997-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 2020-07-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212997-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2020-07-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212997-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2020-07-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212997-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2020-07-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212997-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2020-07-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212997-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 2020-07-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212997-001 | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE | CAPSULE / ORAL | 2020-07-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212997-002 | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE | CAPSULE / ORAL | 2020-07-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212997-003 | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | 2020-07-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212997-004 | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | 2020-07-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212997-005 | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | 2020-07-24 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-11-12 02:37 UTC | 2020-11 | A212997-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A212997-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A212997-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A212997-004 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A212997-005 | AB | 1 | c0c555d07b60… |
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 | 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. | 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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-4062 | Doxepin Hydrochloride | Doxepin Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-4062 | Doxepin Hydrochloride | Doxepin Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-4063 | Doxepin Hydrochloride | Doxepin Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-4063 | Doxepin Hydrochloride | Doxepin Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-4064 | Doxepin Hydrochloride | Doxepin Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-4064 | Doxepin Hydrochloride | Doxepin Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-4065 | Doxepin Hydrochloride | Doxepin Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-4065 | Doxepin Hydrochloride | Doxepin Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-4066 | Doxepin Hydrochloride | Doxepin Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-4066 | Doxepin Hydrochloride | Doxepin Hydrochloride | Lannett Company, Inc. | ANDA | Current |