Details for New Drug Application (NDA): 091323
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The generic ingredient in JENCYCLA is norethindrone. There are twenty-six drug master file entries for this compound. Fifteen 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 |
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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