Details for New Drug Application (NDA): 205588
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The generic ingredient in NORGESTIMATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
Summary for 205588
Tradename: | NORGESTIMATE AND ETHINYL ESTRADIOL |
Applicant: | Lupin Ltd |
Ingredient: | ethinyl estradiol; norgestimate |
Patents: | 0 |
Suppliers and Packaging for NDA: 205588
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NORGESTIMATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norgestimate | TABLET;ORAL-28 | 205588 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-838 | 68180-838-73 | 3 CARTON in 1 CARTON (68180-838-73) / 1 KIT in 1 CARTON |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | ||||
Approval Date: | Apr 26, 2016 | TE: | AB | RLD: | No |
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