Details for New Drug Application (NDA): 209170
NDA 209170 describes DESOGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Duramed Pharms Barr, Annora Pharma, Dr Reddys Labs Sa, Naari Pte, Novast Labs, Watson Labs, and Xiromed, and is included in eleven 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 is one drug master file entry 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 is one drug master file entry for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 209170
| Tradename: | DESOGESTREL AND ETHINYL ESTRADIOL |
| Applicant: | Naari Pte |
| Ingredient: | desogestrel; ethinyl estradiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209170
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESOGESTREL AND ETHINYL ESTRADIOL | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 209170 | ANDA | Naari Pte. Limited | 79929-020 | 79929-020-07 | 3 BLISTER PACK in 1 POUCH (79929-020-07) / 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: | Jun 5, 2017 | TE: | AB | RLD: | No | ||||
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