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Generated: January 20, 2019

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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 two suppliers. 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. Eighteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.
Summary for 091323
Applicant:Lupin Ltd
Formulation / Manufacturing:see details
Pharmacology for NDA: 091323
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 LIMITED 57297-877 57297-877-13 1 BLISTER PACK in 1 CARTON (57297-877-13) > 28 TABLET in 1 BLISTER PACK (57297-877-11)
JENCYCLA norethindrone TABLET;ORAL-28 091323 ANDA Lupin Pharmaceuticals, Inc. 68180-877 68180-877-13 1 BLISTER PACK in 1 CARTON (68180-877-13) > 28 TABLET in 1 BLISTER PACK (68180-877-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.35MG
Approval Date:Mar 28, 2013TE:AB2RLD:No

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