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Generated: April 22, 2019

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Details for New Drug Application (NDA): 084951

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NDA 084951 describes MENEST, which is a drug marketed by Monarch Pharms and is included in four NDAs. It is available from one supplier. Additional details are available on the MENEST profile page.

The generic ingredient in MENEST is estrogens, esterified. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estrogens, esterified profile page.
Summary for 084951
Applicant:Monarch Pharms
Ingredient:estrogens, esterified
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 084951
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MENEST estrogens, esterified TABLET;ORAL 084951 ANDA Pfizer Laboratories Div Pfizer Inc 61570-072 61570-072-01 100 TABLET, FILM COATED in 1 BOTTLE (61570-072-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.3MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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