Details for New Drug Application (NDA): 091636
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NDA 091636 describes ALYACEN 7/7/7, which is a drug marketed by Glenmark Pharms Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the ALYACEN 7/7/7 profile page.
The generic ingredient in ALYACEN 7/7/7 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
The generic ingredient in ALYACEN 7/7/7 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 091636
| Tradename: | ALYACEN 7/7/7 |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | ethinyl estradiol; norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091636
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALYACEN 7/7/7 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 091636 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-556 | 68462-556-29 | 3 BLISTER PACK in 1 CARTON (68462-556-29) / 1 KIT in 1 BLISTER PACK (68462-556-84) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | ||||
| Approval Date: | Jan 19, 2012 | TE: | AB | RLD: | No | ||||
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