Application 016798
- Type
- NDA
- Sponsor
- PFIZER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SINEQUAN | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | SINEQUAN | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | SINEQUAN | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | SINEQUAN | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 006 | SINEQUAN | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 007 | SINEQUAN | DOXEPIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N016798-001 | SINEQUAN | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||
| N016798-002 | SINEQUAN | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||
| N016798-003 | SINEQUAN | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||
| N016798-005 | SINEQUAN | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||
| N016798-006 | SINEQUAN | DOXEPIN HYDROCHLORIDE | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||
| N016798-007 | SINEQUAN | DOXEPIN HYDROCHLORIDE | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 |
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 | N016798-001 | SINEQUAN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016798-002 | SINEQUAN | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016798-003 | SINEQUAN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016798-005 | SINEQUAN | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016798-006 | SINEQUAN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N016798-007 | SINEQUAN | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016798-001 | SINEQUAN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016798-002 | SINEQUAN | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016798-003 | SINEQUAN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016798-005 | SINEQUAN | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016798-006 | SINEQUAN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N016798-007 | SINEQUAN | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016798-001 | SINEQUAN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016798-002 | SINEQUAN | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016798-003 | SINEQUAN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016798-005 | SINEQUAN | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016798-006 | SINEQUAN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N016798-007 | SINEQUAN | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016798-001 | SINEQUAN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016798-002 | SINEQUAN | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016798-003 | SINEQUAN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016798-005 | SINEQUAN | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016798-006 | SINEQUAN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N016798-007 | SINEQUAN | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016798-001 | SINEQUAN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016798-002 | SINEQUAN | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016798-003 | SINEQUAN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016798-005 | SINEQUAN | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016798-006 | SINEQUAN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N016798-007 | SINEQUAN | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016798-001 | SINEQUAN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016798-002 | SINEQUAN | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016798-003 | SINEQUAN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016798-005 | SINEQUAN | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016798-006 | SINEQUAN | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N016798-007 | SINEQUAN | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016798-001 | SINEQUAN | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016798-002 | SINEQUAN | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016798-003 | SINEQUAN | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N016798-005 | SINEQUAN | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | b8a1b40f171c… |
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 | Safecor Health, LLC | a2297f75-c498-419b-aa29-057271313a7f | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 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 | PD-Rx Pharmaceuticals, Inc. | d2a91b99-513d-4894-ad6d-02d2028a2290 | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | 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 | Leading Pharma, LLC | d5df4beb-8048-4b83-aa59-19876437001d | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | 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 | A-S Medication Solutions | e0460c02-3dae-4b19-845c-2ffcfb587f6d | 2025-12-16 | Boxed warning, Warnings, Adverse reactions | 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 | Chartwell RX, LLC | 33a15c3f-bec0-4703-a4e9-f8f78f8b5fd3 | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin hydrochloride | DOXEPIN HYDROCHLORIDE | Ajanta Pharma USA Inc. | 1513c98c-e7ef-4009-b932-6757048bb86a | 2025-11-17 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 8f7e9677-cc84-414b-8eb8-33993d285bb3 | 2025-11-12 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | 09a70f17-f934-4b4b-9277-6351d906ab47 | 2025-10-24 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | 55f7d7b5-b747-49ac-9bf0-1510987b0291 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | 1533343b-f1ed-4c3a-bb36-23a748452b05 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Bryant Ranch Prepack | 94ee3c14-0ccc-4329-b012-63679a699a67 | 2025-10-13 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | First Nation Group, LLC | 3d4f84a4-07a1-4d0e-85f5-dcd43b236a42 | 2025-09-14 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | NorthStar RxLLC | 03cef3a6-a63d-4082-a491-451b24227d9d | 2025-09-14 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Major Pharmaceuticals | df3b6be0-6a64-4174-b351-dab2061f290e | 2025-09-10 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| DOXEPIN HYDROCHLORIDE | DOXEPIN HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 89ed6385-cf6a-458e-81ea-c7f3fead41c5 | 2025-09-09 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Aurobindo Pharma Limited | f3c242dd-426e-4c69-8f21-2645361d5f27 | 2025-09-01 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.