Details for New Drug Application (NDA): 076812
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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
Tradename: | ESTRADIOL AND NORGESTIMATE |
Applicant: | Barr |
Ingredient: | estradiol; norgestimate |
Patents: | 0 |
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 LLC | 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: | RX | Dosage: | TABLET;ORAL | Strength | 1MG,1MG;N/A,0.09MG | ||||
Approval Date: | Apr 29, 2005 | TE: | RLD: | No |
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