Details for New Drug Application (NDA): 201886
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The generic ingredient in VYFEMLA is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 201886
Tradename: | VYFEMLA |
Applicant: | Lupin Ltd |
Ingredient: | ethinyl estradiol; norethindrone |
Patents: | 0 |
Suppliers and Packaging for NDA: 201886
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VYFEMLA | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 201886 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-875 | 68180-875-73 | 3 POUCH in 1 CARTON (68180-875-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (68180-495-74) * 7 TABLET in 1 BLISTER PACK (68180-500-74) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;0.4MG | ||||
Approval Date: | Sep 26, 2013 | TE: | AB | RLD: | No |
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