Details for New Drug Application (NDA): 207976
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NDA 207976 describes HER STYLE, which is a drug marketed by Novast Labs and is included in one NDA. It is available from two suppliers. Additional details are available on the HER STYLE profile page.
The generic ingredient in HER STYLE 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 HER STYLE 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 207976
| Tradename: | HER STYLE |
| Applicant: | Novast Labs |
| Ingredient: | levonorgestrel |
| Patents: | 0 |
Pharmacology for NDA: 207976
| Physiological Effect | Inhibit Ovum Fertilization |
Medical Subject Heading (MeSH) Categories for 207976
Suppliers and Packaging for NDA: 207976
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HER STYLE | levonorgestrel | TABLET;ORAL | 207976 | ANDA | Northstar Rx LLC | 16714-809 | 16714-809-01 | 1 BLISTER PACK in 1 CARTON (16714-809-01) / 1 TABLET in 1 BLISTER PACK |
| HER STYLE | levonorgestrel | TABLET;ORAL | 207976 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-352 | 50742-352-01 | 1 BLISTER PACK in 1 CARTON (50742-352-01) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 1.5MG | ||||
| Approval Date: | Mar 11, 2016 | TE: | RLD: | No | |||||
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