Details for New Drug Application (NDA): 091323
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NDA 091323 describes JENCYCLA, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the JENCYCLA profile page.
The generic ingredient in JENCYCLA is norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.
The generic ingredient in JENCYCLA is norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.
Summary for 091323
| Tradename: | JENCYCLA |
| Applicant: | Lupin Ltd |
| Ingredient: | norethindrone |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 091323
Suppliers and Packaging for NDA: 091323
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JENCYCLA | norethindrone | TABLET;ORAL-28 | 091323 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-877 | 68180-877-73 | 1 BLISTER PACK in 1 CARTON (68180-877-73) / 28 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.35MG | ||||
| Approval Date: | Mar 28, 2013 | TE: | AB2 | RLD: | No | ||||
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