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Details for New Drug Application (NDA): 206229

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NDA 206229 describes LILETTA, which is a drug marketed by Medicines360 and is included in one NDA. It is available from two suppliers. Additional details are available on the LILETTA profile page.

The generic ingredient in LILETTA is levonorgestrel. There are twenty drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.

Summary for NDA: 206229

Pharmacology for NDA: 206229

Ingredient-typeProgesterone Congeners
Physiological EffectInhibit Ovum Fertilization

Suppliers and Packaging for NDA: 206229

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INTRAUTERINE DEVICE;INTRAUTERINE 206229 NDA Allergan, Inc. 0023-5858 0023-5858-01 1 TRAY in 1 CARTON (0023-5858-01) > 1 INTRAUTERINE DEVICE in 1 TRAY
INTRAUTERINE DEVICE;INTRAUTERINE 206229 NDA Actavis Pharma, Inc. 52544-035 52544-035-54 1 POUCH in 1 CARTON (52544-035-54) > 1 INTRAUTERINE DEVICE in 1 POUCH

Summary for product number 001

Approval Date:Feb 26, 2015TE:RLD:No
Regulatory Exclusivity Expiration:Feb 26, 2018
Regulatory Exclusivity Use:NEW PRODUCT

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