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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 thirteen 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 NDA: 018066

Tradename:
UNISOM
Applicant:
Chattem
Ingredient:
doxylamine succinate
Patents:0
Formulation / Manufacturing:see details

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 41167-0060-3 3 BLISTER PACK in 1 CARTON (41167-0060-3) > 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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