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HYDROCHLORIDE | CAPSULE;ORAL | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | CAPSULE;ORAL | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | CAPSULE;ORAL | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | CAPSULE;ORAL | EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| SINEQUAN | DOXEPIN HYDROCHLORIDE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||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| SINEQUAN | DOXEPIN HYDROCHLORIDE | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||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| SINEQUAN | DOXEPIN HYDROCHLORIDE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||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SINEQUAN | DOXEPIN HYDROCHLORIDE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||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 | Appco Pharma LLC | abf4c515-8888-4733-80a0-fd4e1cdb84a2 | 2021-04-29 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Proficient Rx LP | e98f371e-f7fe-4c8f-9491-6eb4c53d43ad | 2021-02-01 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Contract Pharmacal Corp. | abbf7078-a012-4e1a-e053-2995a90a792d | 2020-08-06 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 10d9eba6-30d1-448a-8d92-a1a02df03303 | 2017-09-05 | Boxed warning, Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| PRUDOXIN | DOXEPIN HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | ca53346b-8ab3-4722-98f6-cf272706d3fa | 2017-06-29 | Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Zonalon | DOXEPIN HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | 5f302247-525e-4acc-852b-00eb1d79af4b | 2017-06-14 | Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
| Doxepin Hydrochloride | DOXEPIN HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | b4771ea7-c19b-4182-bb23-c1473ab583fa | 2017-05-24 | Warnings, Adverse reactions | DOXEPIN HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.