Details for New Drug Application (NDA): 202016
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NDA 202016 describes MELAMISA, which is a drug marketed by Novast Labs and is included in one NDA. It is available from one supplier. Additional details are available on the MELAMISA profile page.
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.
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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