Details for New Drug Application (NDA): 090114
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NDA 090114 describes SYEDA, which is a drug marketed by Xiromed and is included in one NDA. It is available from two suppliers. Additional details are available on the SYEDA profile page.
The generic ingredient in SYEDA is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
The generic ingredient in SYEDA is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
Summary for 090114
| Tradename: | SYEDA |
| Applicant: | Xiromed |
| Ingredient: | drospirenone; ethinyl estradiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090114
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SYEDA | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 090114 | ANDA | Bryant Ranch Prepack | 63629-2335 | 63629-2335-1 | 3 BLISTER PACK in 1 CARTON (63629-2335-1) / 1 KIT in 1 BLISTER PACK |
| SYEDA | drospirenone; ethinyl estradiol | TABLET;ORAL-28 | 090114 | ANDA | Xiromed, LLC. | 70700-115 | 70700-115-85 | 3 BLISTER PACK in 1 CARTON (70700-115-85) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 3MG;0.03MG | ||||
| Approval Date: | Mar 28, 2011 | TE: | AB | RLD: | No | ||||
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