Details for New Drug Application (NDA): 205947
NDA 205947 describes DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM, which is a drug marketed by Lupin and Watson Labs Inc and is included in three NDAs. It is available from one supplier. Additional details are available on the DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM profile page.
The generic ingredient in DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM is drospirenone; ethinyl estradiol; levomefolate calcium. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.
The generic ingredient in DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM is drospirenone; ethinyl estradiol; levomefolate calcium. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.
Summary for 205947
| Tradename: | DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM |
| Applicant: | Lupin |
| Ingredient: | drospirenone; ethinyl estradiol; levomefolate calcium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205947
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 205947 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-894 | 68180-894-73 | 3 POUCH in 1 CARTON (68180-894-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG | ||||
| Approval Date: | Jun 13, 2018 | TE: | AB | RLD: | No | ||||
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