Details for New Drug Application (NDA): 091234
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NDA 091234 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. Sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 091234
| Tradename: | DESOGESTREL AND ETHINYL ESTRADIOL |
| Applicant: | Novast Labs |
| Ingredient: | desogestrel; ethinyl estradiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091234
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DESOGESTREL AND ETHINYL ESTRADIOL | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 091234 | ANDA | Northstar Rx LLC | 16714-464 | 16714-464-01 | 1 BLISTER PACK in 1 PACKET (16714-464-01) / 1 KIT in 1 BLISTER PACK |
| DESOGESTREL AND ETHINYL ESTRADIOL | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 091234 | ANDA | Northstar Rx LLC | 16714-464 | 16714-464-02 | 1 BLISTER PACK in 1 CARTON (16714-464-02) / 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: | Jul 12, 2013 | TE: | AB | RLD: | No | ||||
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