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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 073594

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NDA 073594 describes LEVORA 0.15/30-28, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from four suppliers. Additional details are available on the LEVORA 0.15/30-28 profile page.

The generic ingredient in LEVORA 0.15/30-28 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 073594
Tradename:LEVORA 0.15/30-28
Applicant:Mayne Pharma
Ingredient:ethinyl estradiol; levonorgestrel
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 073594
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVORA 0.15/30-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 073594 ANDA Rebel Distributors Corp 42254-260 42254-260-28 1 BLISTER PACK in 1 CARTON (42254-260-28) > 1 KIT in 1 BLISTER PACK
LEVORA 0.15/30-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 073594 ANDA Mayne Pharma Inc. 51862-097 51862-097-06 6 BLISTER PACK in 1 CARTON (51862-097-06) > 1 KIT in 1 BLISTER PACK (51862-097-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.03MG;0.15MG
Approval Date:Dec 13, 1993TE:ABRLD:No

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