Details for New Drug Application (NDA): 202016
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The generic ingredient in MELAMISA is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
Summary for 202016
Tradename: | MELAMISA |
Applicant: | Novast Labs |
Ingredient: | drospirenone; ethinyl estradiol |
Patents: | 0 |
Suppliers and Packaging for NDA: 202016
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MELAMISA | drospirenone; ethinyl estradiol | TABLET;ORAL | 202016 | ANDA | Nivagen Pharmaceuticals, Inc. | 75834-116 | 75834-116-29 | 3 BLISTER PACK in 1 CARTON (75834-116-29) / 1 KIT in 1 BLISTER PACK |
MELAMISA | drospirenone; ethinyl estradiol | TABLET;ORAL | 202016 | ANDA | Nivagen Pharmaceuticals, Inc. | 75834-116 | 75834-116-84 | 1 BLISTER PACK in 1 PACKET (75834-116-84) / 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: | Jan 26, 2016 | TE: | AB | RLD: | No |
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