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Generated: February 18, 2019

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Details for New Drug Application (NDA): 001546

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NDA 001546 describes GUANIDINE HYDROCHLORIDE, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. Additional details are available on the GUANIDINE HYDROCHLORIDE profile page.

The generic ingredient in GUANIDINE HYDROCHLORIDE is guanidine hydrochloride. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the guanidine hydrochloride profile page.
Summary for 001546
Applicant:Merck Sharp Dohme
Ingredient:guanidine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 001546
Suppliers and Packaging for NDA: 001546
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUANIDINE HYDROCHLORIDE guanidine hydrochloride TABLET;ORAL 001546 NDA Merck Sharp & Dohme Corp. 0085-0492 0085-0492-01 100 TABLET in 1 BOTTLE (0085-0492-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength125MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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