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Details for New Drug Application (NDA): 202246

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NDA 202246 describes LEVONORGESTREL, which is a drug marketed by Novel Labs Inc, Wyeth Pharms Inc, Lupin Ltd, Perrigo R And D, Jai Pharma Ltd, Glenmark Pharms Ltd, Lotus Pharm Co Ltd, Watson Labs, Watson Labs Inc, Oc Pharma, Mayne Pharma, Amneal Pharms, Barr, Haupt Pharma, and Glenmark Generics, and is included in thirty-six NDAs. It is available from eighteen suppliers. Additional details are available on the LEVONORGESTREL profile page.

The generic ingredient in LEVONORGESTREL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for NDA: 202246

Tradename:
LEVONORGESTREL
Applicant:
Lotus Pharm Co Ltd
Ingredient:
levonorgestrel
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 202246

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONORGESTREL
levonorgestrel
TABLET;ORAL 202246 ANDA Lotus Pharmaceutical Co., Ltd. Nantou Plant 40051-018 40051-018-22 1 TABLET in 1 CARTON (40051-018-22)
LEVONORGESTREL
levonorgestrel
TABLET;ORAL 202246 ANDA Wockhardt USA, LLC 64679-050 64679-050-02 1 BLISTER PACK in 1 CARTON (64679-050-02) > 1 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength1.5MG
Approval Date:Jun 5, 2015TE:RLD:No


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