Details for New Drug Application (NDA): 201887
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NDA 201887 describes ENSKYCE, 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 ENSKYCE profile page.
The generic ingredient in ENSKYCE is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
The generic ingredient in ENSKYCE is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 201887
| Tradename: | ENSKYCE |
| Applicant: | Lupin Ltd |
| Ingredient: | desogestrel; ethinyl estradiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 201887
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENSKYCE | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 201887 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-739 | 68180-739-73 | 3 POUCH in 1 CARTON (68180-739-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 21 TABLET, FILM COATED in 1 BLISTER PACK (68180-787-74) * 7 TABLET in 1 BLISTER PACK (68180-794-74) |
| ENSKYCE | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 201887 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-891 | 68180-891-73 | 3 POUCH in 1 CARTON (68180-891-73) / 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-28 | Strength | 0.15MG;0.03MG | ||||
| Approval Date: | Mar 7, 2013 | TE: | AB | RLD: | No | ||||
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