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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 207825


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NDA 207825 describes DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Bionpharma, Endo Operations, and Mylan Pharms Inc, and is included in five NDAs. It is available from five suppliers. Additional details are available on the DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE profile page.

The generic ingredient in DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE is doxylamine succinate; pyridoxine hydrochloride. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the doxylamine succinate; pyridoxine hydrochloride profile page.
Pharmacology for NDA: 207825
Suppliers and Packaging for NDA: 207825
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE doxylamine succinate; pyridoxine hydrochloride TABLET, DELAYED RELEASE;ORAL 207825 ANDA Mylan Pharmaceuticals Inc. 0378-4615 0378-4615-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4615-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength10MG;10MG
Approval Date:Jul 6, 2020TE:ABRLD:No

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