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Generated: October 16, 2018

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Details for New Drug Application (NDA): 203164

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NDA 203164 describes LEVONORGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Amneal Pharms, Glenmark Generics, Glenmark Pharms Ltd, Lupin Ltd, Mylan Labs Ltd, Watson Labs, Barr, Mayne Pharma, and Labs Leon Farma, and is included in twenty-five NDAs. It is available from twelve suppliers. Additional details are available on the LEVONORGESTREL AND ETHINYL ESTRADIOL profile page.

The generic ingredient in LEVONORGESTREL AND ETHINYL ESTRADIOL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 203164
Suppliers and Packaging for NDA: 203164
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 203164 ANDA Glenmark Pharmaceuticals Inc., USA 68462-672 68462-672-95 3 POUCH in 1 CARTON (68462-672-95) > 1 BLISTER PACK in 1 POUCH (68462-672-91) > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.03MG;0.15MG
Approval Date:Jun 12, 2015TE:ABRLD:No

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