Details for New Drug Application (NDA): 201446
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NDA 201446 describes FALLBACK SOLO, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from five suppliers. Additional details are available on the FALLBACK SOLO profile page.
The generic ingredient in FALLBACK SOLO is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
The generic ingredient in FALLBACK SOLO is levonorgestrel. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
Summary for 201446
| Tradename: | FALLBACK SOLO |
| Applicant: | Lupin Ltd |
| Ingredient: | levonorgestrel |
| Patents: | 0 |
Pharmacology for NDA: 201446
| Physiological Effect | Inhibit Ovum Fertilization |
Medical Subject Heading (MeSH) Categories for 201446
Suppliers and Packaging for NDA: 201446
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FALLBACK SOLO | levonorgestrel | TABLET;ORAL | 201446 | ANDA | LUPIN LIMITED | 57297-852 | 57297-852-11 | 1 BLISTER PACK in 1 CARTON (57297-852-11) / 1 TABLET in 1 BLISTER PACK |
| FALLBACK SOLO | levonorgestrel | TABLET;ORAL | 201446 | ANDA | Syzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880 | 64122-605 | 64122-605-01 | 1 TABLET in 1 BLISTER PACK (64122-605-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 1.5MG | ||||
| Approval Date: | Jun 19, 2014 | TE: | RLD: | No | |||||
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