Details for New Drug Application (NDA): 209405
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The generic ingredient in TYBLUME 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 209405
Tradename: | TYBLUME |
Applicant: | Exeltis Usa Inc |
Ingredient: | ethinyl estradiol; levonorgestrel |
Patents: | 0 |
Suppliers and Packaging for NDA: 209405
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TYBLUME | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 209405 | NDA | Exeltis USA, Inc. | 0642-7471 | 0642-7471-01 | 1 BLISTER PACK in 1 BOX (0642-7471-01) / 1 KIT in 1 BLISTER PACK |
TYBLUME | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 209405 | NDA | Exeltis USA, Inc. | 0642-7471 | 0642-7471-02 | 1 BLISTER PACK in 1 BOX (0642-7471-02) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.02MG;0.1MG | ||||
Approval Date: | Mar 30, 2020 | TE: | RLD: | Yes |
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