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UNISOM

NDA

DOXYLAMINE SUCCINATE | N019440 | PFIZER LABORATORIES DIV PFIZER INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain8 active DMFs8 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

CORDEN PHARMA BERGAMO SPADOXYLAMINE SUCCINATE

DMF 47411982

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)DOXYLAMINE SUCCINATE USP

DMF 53991984

SIGMA ALDRICH IRELAND LTDDOXYLAMINE SUCCINATE USP

DMF 69081987

RL FINE CHEM PVT LTDDOXYLAMINE SUCCINATE

DMF 280272014

SHENZHEN ORIENTAL PHARMACEUTICAL CO LTDDOXYLAMINE SUCCINATE

DMF 318312017

HONOUR LAB LTDDOXYLAMINE SUCCINATE

DMF 374762022

MALLADI DRUGS AND PHARMACEUTICALS LTDDOXYLAMINE SUCCINATE

DMF 384872023

HY-GRO CHEMICALS PHARMTEK PRIVATE LTDDOXYLAMINE SUCCINATE

DMF 416952025

HOFFMANN LA ROCHE INCInactiveDOXYLAMINE SUCCINATE

DMF 36521979

BURDICK & JACKSON LABS,INCInactiveDOXYLAMINE SUCCINATE

DMF 36731979

POLIPHARM SPAInactiveDOXYLAMINE SUCCINATE USP

DMF 39221980

MALLINCKRODT PHARMS DIV MALLINCKRODT INCInactiveDOXYLAMINE SUCCINATE USP AS PRODUCED IN THE ST. LOUIS MO PLANT

DMF 40591981

YODOGAWA PHARMACEUTICAL CO LTDInactiveDOXYLAMINE SUCCINATE USP XXI

DMF 56891985

JT BAKER CHEMICAL COInactiveDOXYLAMINE SUCCINATE

DMF 70761987

ARCHIMICA SPAInactiveDOXYLAMINE SUCCINATE USP

DMF 72151987

UQUIFA ITALIA SPAInactiveDOXYLAMINE SUCCINATE USP

DMF 174172004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 25MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Feb 5, 1986

No patent or exclusivity listings for this strength.