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Generated: June 27, 2019

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Details for New Drug Application (NDA): 076812

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NDA 076812 describes ESTRADIOL AND NORGESTIMATE, which is a drug marketed by Barr and is included in one NDA. It is available from one supplier. Additional details are available on the ESTRADIOL AND NORGESTIMATE profile page.

The generic ingredient in ESTRADIOL AND NORGESTIMATE is estradiol; norgestimate. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol; norgestimate profile page.
Summary for 076812
Ingredient:estradiol; norgestimate
Suppliers and Packaging for NDA: 076812
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL AND NORGESTIMATE estradiol; norgestimate TABLET;ORAL 076812 ANDA Teva Women's Health, Inc. 51285-063 51285-063-90 6 POUCH in 1 CARTON (51285-063-90) > 1 BLISTER PACK in 1 POUCH (51285-063-89) > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG,1MG;N/A,0.09MG
Approval Date:Apr 29, 2005TE:RLD:No

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