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Details for New Drug Application (NDA): 007638

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NDA 007638 describes CHLOR-TRIMETON, which is a drug marketed by Schering, Schering Plough, and Bayer Healthcare Llc, and is included in five NDAs. It is available from one supplier. Additional details are available on the CHLOR-TRIMETON profile page.

The generic ingredient in CHLOR-TRIMETON is chlorpheniramine maleate; pseudoephedrine sulfate. There are twenty-nine drug master file entries for this compound. Additional details are available on the chlorpheniramine maleate; pseudoephedrine sulfate profile page.

Summary for NDA: 007638

Bayer Healthcare Llc
chlorpheniramine maleate
Therapeutic Class:Respiratory Tract Agents

Suppliers and Packaging for NDA: 007638

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
chlorpheniramine maleate
TABLET, EXTENDED RELEASE;ORAL 007638 NDA Schering Plough HealthCare Products 11523-0728 11523-0728-1 1 BLISTER PACK in 1 CARTON (11523-0728-1) > 24 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 001

Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength12MG
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.