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Generated: November 14, 2018

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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-nine suppliers are listed for this compound. Additional details are available on the doxylamine succinate profile page.
Summary for 018066
Ingredient:doxylamine succinate
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 41167-0060-7 2 BLISTER PACK in 1 CARTON (41167-0060-7) > 8 TABLET in 1 BLISTER PACK

Profile 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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