Details for New Drug Application (NDA): 202789
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NDA 202789 describes ISIBLOOM, 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 ISIBLOOM profile page.
The generic ingredient in ISIBLOOM 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 ISIBLOOM 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 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 | Par Pharmaceutical, Inc. | 0254-2033 | 0254-2033-73 | 3 CARTON in 1 CARTON (0254-2033-73) / 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK |
| ISIBLOOM | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 202789 | ANDA | Par Pharmaceutical, Inc. | 0254-2033 | 0254-2033-80 | 6 CARTON in 1 CARTON (0254-2033-80) / 1 BLISTER PACK in 1 CARTON / 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 | ||||
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