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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018066

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NDA 018066 describes UNISOM, which is a drug marketed by Pfizer and Chattem and is included in two NDAs. It is available from one supplier. Additional details are available on the UNISOM profile page.

The generic ingredient in UNISOM is doxylamine succinate. There are fourteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the doxylamine succinate profile page.

Summary for 018066

Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 018066

Suppliers and Packaging for NDA: 018066

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
UNISOM doxylamine succinate TABLET;ORAL 018066 NDA Chattem, Inc. 41167-0060 41167-0060-2 5 BLISTER PACK in 1 CARTON (41167-0060-2) > 16 TABLET in 1 BLISTER PACK
UNISOM doxylamine succinate TABLET;ORAL 018066 NDA Chattem, Inc. 41167-0060 41167-0060-9 2 BLISTER PACK in 1 CARTON (41167-0060-9) > 16 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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