Details for New Drug Application (NDA): 091634
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NDA 091634 describes ALYACEN 1/35, which is a drug marketed by Glenmark Pharms Ltd and is included in one NDA. It is available from three suppliers. Additional details are available on the ALYACEN 1/35 profile page.
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.
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 | Glenmark Pharmaceuticals Inc., USA | 68462-394 | 68462-394-29 | 3 BLISTER PACK in 1 CARTON (68462-394-29) / 1 KIT in 1 BLISTER PACK (68462-394-84) |
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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