Details for New Drug Application (NDA): 203770
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The generic ingredient in JAIMIESS is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 203770
Tradename: | JAIMIESS |
Applicant: | Xiromed |
Ingredient: | ethinyl estradiol; levonorgestrel |
Patents: | 0 |
Suppliers and Packaging for NDA: 203770
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
JAIMIESS | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 203770 | ANDA | Bryant Ranch Prepack | 63629-2345 | 63629-2345-1 | 1 BLISTER PACK in 1 BOX (63629-2345-1) / 1 KIT in 1 BLISTER PACK |
JAIMIESS | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 203770 | ANDA | Xiromed, LLC. | 70700-123 | 70700-123-87 | 1 BLISTER PACK in 1 BOX (70700-123-87) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.03MG,0.01MG;0.15MG,N/A | ||||
Approval Date: | Dec 27, 2017 | TE: | AB | RLD: | No |
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