Details for New Drug Application (NDA): 207245
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The generic ingredient in DROSPIRENONE AND ETHINYL ESTRADIOL 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 207245
Tradename: | DROSPIRENONE AND ETHINYL ESTRADIOL |
Applicant: | Naari Pte Ltd |
Ingredient: | drospirenone; ethinyl estradiol |
Patents: | 0 |
Suppliers and Packaging for NDA: 207245
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 207245 | ANDA | Naari Pte. Limited | 79929-019 | 79929-019-07 | 3 BLISTER PACK in 1 POUCH (79929-019-07) / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 3MG;0.03MG | ||||
Approval Date: | Nov 22, 2016 | TE: | AB | RLD: | No |
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