Details for New Drug Application (NDA): 091634
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The generic ingredient in ALYACEN 1/35 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 091634
Tradename: | ALYACEN 1/35 |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | ethinyl estradiol; norethindrone |
Patents: | 0 |
Suppliers and Packaging for NDA: 091634
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALYACEN 1/35 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 091634 | ANDA | A-S Medication Solutions | 50090-1477 | 50090-1477-0 | 1 KIT in 1 KIT (50090-1477-0) |
ALYACEN 1/35 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 091634 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1780 | 53002-1780-1 | 1 KIT in 1 BLISTER PACK (53002-1780-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;1MG | ||||
Approval Date: | Jan 19, 2012 | TE: | AB | RLD: | No |
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