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Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078912

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NDA 078912 describes GUAIFENESIN, which is a drug marketed by Actavis Labs Fl, Perrigo R And D, and Aurobindo Pharma Ltd, and is included in five NDAs. It is available from thirty-five suppliers. Additional details are available on the GUAIFENESIN profile page.

The generic ingredient in GUAIFENESIN is guaifenesin; pseudoephedrine hydrochloride. There are twenty drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.

Summary for NDA: 078912

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078912

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUAIFENESIN
guaifenesin
TABLET, EXTENDED RELEASE;ORAL 078912 ANDA L. Perrigo Company 0113-0498 0113-0498-58 1 BOTTLE in 1 CARTON (0113-0498-58) > 40 TABLET, EXTENDED RELEASE in 1 BOTTLE
GUAIFENESIN
guaifenesin
TABLET, EXTENDED RELEASE;ORAL 078912 ANDA L. Perrigo Company 0113-0498 0113-0498-60 1 BOTTLE in 1 CARTON (0113-0498-60) > 20 TABLET, EXTENDED RELEASE in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Nov 23, 2011TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

UBS
Johnson and Johnson
Deloitte
Julphar
Daiichi Sankyo
Argus Health
Boehringer Ingelheim
Federal Trade Commission
Moodys
Healthtrust

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