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Details for New Drug Application (NDA): 209405
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NDA 209405 describes TYBLUME, which is a drug marketed by Exeltis Usa Inc and is included in one NDA. It is available from one supplier. Additional details are available on the TYBLUME profile page.
The generic ingredient in TYBLUME is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
The generic ingredient in TYBLUME is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-one 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 | 0642-7471-03 | 3 BLISTER PACK in 1 BOX (0642-7471-03) > 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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