Details for New Drug Application (NDA): 202789
✉ Email this page to a colleague
NDA 202789 describes ISIBLOOM, which is a drug marketed by Xiromed and is included in one NDA. It is available from one supplier. Additional details are available on the ISIBLOOM profile page.
The generic ingredient in ISIBLOOM 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 ISIBLOOM 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 202789
| Tradename: | ISIBLOOM |
| Applicant: | Xiromed |
| Ingredient: | desogestrel; ethinyl estradiol |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202789
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISIBLOOM | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 202789 | ANDA | Xiromed, LLC. | 70700-113 | 70700-113-85 | 3 BLISTER PACK in 1 CARTON (70700-113-85) / 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: | Aug 12, 2015 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
