FDA.reportPublic FDA data

Application 017516

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SINEQUANDOXEPIN HYDROCHLORIDECONCENTRATE;ORALEQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017516-001SINEQUANDOXEPIN HYDROCHLORIDEEQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CONCENTRATE / ORALRLD, Approved before 1982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.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N017516-001SINEQUANEQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CONCENTRATE / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017516-001SINEQUANEQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CONCENTRATE / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017516-001SINEQUANEQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CONCENTRATE / ORALRLD, Approved before 1982a50c72e98297…

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.

Matched openFDA labels page 1 of 5 · 87 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoxepinDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.2a9c2159-e89e-47e4-b91c-ac5560607a2d2026-09-04Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.21dc77be-23af-4a1f-b189-dfee8ae2f8942026-09-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.7a8c56ab-5dd1-4e1a-b26a-3af45b961dd02026-09-03Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.670edc2b-7914-479e-b4dd-d5c86706a6312026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.d29a8c70-cf1c-4bf8-bb87-1c80babce64e2026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.90d9041f-985b-470b-8cbb-f05dbfc770c92026-09-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.5ee0f8e6-df05-4166-a614-77e124db95ae2026-08-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.99ff6e3e-8c12-4393-96ae-206d86d269472026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.0ae2e882-2570-404b-8529-0414eee5f95a2026-08-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
doxepin hydrochlorideDOXEPIN HYDROCHLORIDEGolden State Medical Supply, Inc.57efdc34-d619-e413-e063-6394a90a0e042026-07-31Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDENovadoz Pharmaceuticals LLC2b1f0144-65d8-451f-8054-6be1675f102c2026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDENovadoz Pharmaceuticals LLC96086fd8-8fa3-4a2b-ac12-fe1a3ad4f3842026-07-23Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEA-S Medication Solutions78cf65ff-43f9-4f5e-95dd-864acc89c02a2026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEProficient Rx LPd7a6768a-927b-4f51-858d-1ddfa9d5c5d32026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.46be666a-fb9f-42a5-a55c-ea15fd5538c92026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDEREMEDYREPACK INC.4ecd3b43-b5f1-4cf4-af36-eb214c1a3c602026-06-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDECoupler LLC54616c93-2325-4719-e063-6394a90a39102026-06-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin hydrochlorideDOXEPIN HYDROCHLORIDECoupler LLC538643c0-b8d1-d71f-e063-6294a90a77342026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
SilenorDOXEPIN HYDROCHLORIDECurrax Pharmaceuticals LLC1bec1223-5239-4eb6-a9e8-62444106d2c02026-04-21Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE
Doxepin HydrochlorideDOXEPIN HYDROCHLORIDEBryant Ranch Prepackc577af7c-2405-4454-a169-5b6a4fa0c7bf2026-04-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DOXEPIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82751SUPPL 2025-07-08
82750SUPPL 2025-07-08
82741SUPPL 2025-07-08
13164SUPPL2014-07-15
11006SUPPL2014-07-15
20074ORIG2009-11-02
613SUPPL2007-08-07
33290SUPPL2007-08-03
44011ORIG2007-05-09
612SUPPL2005-02-23
611SUPPL2003-10-09