Details for New Drug Application (NDA): 213034
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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 213034
Tradename: | DROSPIRENONE AND ETHINYL ESTRADIOL |
Applicant: | Hetero Labs |
Ingredient: | drospirenone; ethinyl estradiol |
Patents: | 0 |
Suppliers and Packaging for NDA: 213034
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 213034 | ANDA | Camber Pharmaceuticals, Inc. | 31722-945 | 31722-945-31 | 3 BLISTER PACK in 1 CARTON (31722-945-31) / 1 KIT in 1 BLISTER PACK (31722-945-28) |
DROSPIRENONE AND ETHINYL ESTRADIOL | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 213034 | ANDA | Camber Pharmaceuticals, Inc. | 31722-945 | 31722-945-32 | 1 BLISTER PACK in 1 CARTON (31722-945-32) / 1 KIT in 1 BLISTER PACK (31722-945-28) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 3MG;0.03MG | ||||
Approval Date: | Jan 24, 2020 | TE: | AB | RLD: | No |
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