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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 202791


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NDA 202791 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, Dr Reddys Labs Sa, Hetero Labs, Naari Pte Ltd, and Xiromed, and is included in twenty-nine NDAs. It is available from ten 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-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 202791
Pharmacology for NDA: 202791
Mechanism of ActionEstrogen Receptor Agonists
Physiological EffectInhibit Ovum Fertilization
Suppliers and Packaging for NDA: 202791
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 202791 ANDA Glenmark Pharmaceuticals Inc., USA 68462-637 68462-637-29 3 POUCH in 1 CARTON (68462-637-29) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.02MG;0.09MG
Approval Date:Apr 9, 2015TE:ABRLD:No

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