Details for New Drug Application (NDA): 202296
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NDA 202296 describes DESOGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Duramed Pharms Barr, Dr Reddys Labs Sa, Naari Pte Ltd, Novast Labs, Watson Labs, and Xiromed, and is included in nine NDAs. It is available from eight suppliers. Additional details are available on the DESOGESTREL AND ETHINYL ESTRADIOL profile page.
The generic ingredient in DESOGESTREL AND ETHINYL ESTRADIOL is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
The generic ingredient in DESOGESTREL AND ETHINYL ESTRADIOL is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 202296
| Tradename: | DESOGESTREL AND ETHINYL ESTRADIOL |
| Applicant: | Xiromed |
| Ingredient: | desogestrel; ethinyl estradiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202296
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESOGESTREL AND ETHINYL ESTRADIOL | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 202296 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7296 | 0378-7296-53 | 3 POUCH in 1 CARTON (0378-7296-53) / 1 BLISTER PACK in 1 POUCH (0378-7296-85) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.15MG,N/A;0.02MG,0.01MG | ||||
| Approval Date: | Aug 30, 2013 | TE: | AB | RLD: | No | ||||
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