Details for New Drug Application (NDA): 205948
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NDA 205948 describes TYDEMY, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the TYDEMY profile page.
The generic ingredient in TYDEMY 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 TYDEMY 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 205948
| Tradename: | TYDEMY |
| Applicant: | Lupin Ltd |
| Ingredient: | drospirenone; ethinyl estradiol; levomefolate calcium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205948
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TYDEMY | drospirenone; ethinyl estradiol; levomefolate calcium | TABLET;ORAL | 205948 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-904 | 68180-904-73 | 3 POUCH in 1 CARTON (68180-904-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 21 TABLET, FILM COATED in 1 BLISTER PACK (68180-905-74) * 7 TABLET, FILM COATED in 1 BLISTER PACK (68180-910-74) |
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: | Dec 12, 2017 | TE: | AB | RLD: | No | ||||
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