Details for New Drug Application (NDA): 203594
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NDA 203594 describes DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM, which is a drug marketed by Lupin Ltd 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 are eleven drug master file entries 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 are eleven drug master file entries 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 203594
| Tradename: | DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM |
| Applicant: | Watson Labs Inc |
| Ingredient: | drospirenone; ethinyl estradiol; levomefolate calcium |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG | ||||
| Approval Date: | Oct 11, 2016 | TE: | AB | RLD: | No | ||||
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