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HYDROCHLORIDE | CAPSULE;ORAL | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | CAPSULE;ORAL | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | CAPSULE;ORAL | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| SINEQUAN | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||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| SINEQUAN | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||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| SINEQUAN | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||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SINEQUAN | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | 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 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | 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 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | 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 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | 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 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | 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 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | 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 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | 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 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | 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 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | 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 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | 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 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | 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 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | 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 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | 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 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | 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 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | 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 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | 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 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N016798-001 | SINEQUAN | EQ 25MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N016798-002 | SINEQUAN | EQ 50MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N016798-003 | SINEQUAN | EQ 10MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N016798-005 | SINEQUAN | EQ 100MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N016798-006 | SINEQUAN | EQ 75MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | 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 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N016798-001 | SINEQUAN | EQ 25MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N016798-002 | SINEQUAN | EQ 50MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N016798-003 | SINEQUAN | EQ 10MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N016798-005 | SINEQUAN | EQ 100MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N016798-006 | SINEQUAN | EQ 75MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | 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 | 4b0b4de00fa7… |
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 | REMEDYREPACK INC. | 7a8c56ab-5dd1-4e1a-b26a-3af45b961dd0 | 2026-09-03 | Warnings, Adverse reactions | 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 | REMEDYREPACK INC. | d29a8c70-cf1c-4bf8-bb87-1c80babce64e | 2026-09-01 | Boxed warning, Warnings, Adverse reactions | 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 | REMEDYREPACK INC. | 5ee0f8e6-df05-4166-a614-77e124db95ae | 2026-08-31 | Boxed warning, Warnings, Adverse reactions | 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 | REMEDYREPACK INC. | 0ae2e882-2570-404b-8529-0414eee5f95a | 2026-08-24 | Boxed warning, Warnings, Adverse reactions | 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 | Novadoz Pharmaceuticals LLC | 2b1f0144-65d8-451f-8054-6be1675f102c | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | 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 | A-S Medication Solutions | 78cf65ff-43f9-4f5e-95dd-864acc89c02a | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 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 | REMEDYREPACK INC. | 46be666a-fb9f-42a5-a55c-ea15fd5538c9 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | 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 | Coupler LLC | 54616c93-2325-4719-e063-6394a90a3910 | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin hydrochloride | DOXEPIN HYDROCHLORIDE | Coupler LLC | 538643c0-b8d1-d71f-e063-6294a90a7734 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.