Details for New Drug Application (NDA): 206867
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NDA 206867 describes ATHENTIA NEXT, which is a drug marketed by Aurobindo Pharma and is included in one NDA. It is available from seven suppliers. Additional details are available on the ATHENTIA NEXT profile page.
The generic ingredient in ATHENTIA NEXT 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 ATHENTIA NEXT 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 206867
| Tradename: | ATHENTIA NEXT |
| Applicant: | Aurobindo Pharma |
| Ingredient: | levonorgestrel |
| Patents: | 0 |
Pharmacology for NDA: 206867
| Physiological Effect | Inhibit Ovum Fertilization |
Medical Subject Heading (MeSH) Categories for 206867
Suppliers and Packaging for NDA: 206867
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ATHENTIA NEXT | levonorgestrel | TABLET;ORAL | 206867 | ANDA | Rugby Laboratories | 0536-1433 | 0536-1433-63 | 1 BLISTER PACK in 1 CARTON (0536-1433-63) / 1 TABLET in 1 BLISTER PACK |
| ATHENTIA NEXT | levonorgestrel | TABLET;ORAL | 206867 | ANDA | Afaxys Pharma, LLC | 50102-211 | 50102-211-13 | 3 CARTON in 1 PACKAGE (50102-211-13) / 1 BLISTER PACK in 1 CARTON (50102-211-11) / 1 TABLET in 1 BLISTER PACK (50102-211-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 1.5MG | ||||
| Approval Date: | Dec 8, 2015 | TE: | RLD: | No | |||||
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