Details for New Drug Application (NDA): 201661
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NDA 201661 describes NIKKI, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the NIKKI profile page.
The generic ingredient in NIKKI is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
The generic ingredient in NIKKI is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
Summary for 201661
| Tradename: | NIKKI |
| Applicant: | Lupin Ltd |
| Ingredient: | drospirenone; ethinyl estradiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 201661
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NIKKI | drospirenone; ethinyl estradiol | TABLET;ORAL | 201661 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-886 | 68180-886-73 | 3 BLISTER PACK in 1 CARTON (68180-886-73) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG;0.02MG | ||||
| Approval Date: | May 27, 2014 | TE: | AB | RLD: | No | ||||
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