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Generated: September 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074538

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NDA 074538 describes TRIVORA-28, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from three suppliers. Additional details are available on the TRIVORA-28 profile page.

The generic ingredient in TRIVORA-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 NDA: 074538

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 074538

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIVORA-21
ethinyl estradiol; levonorgestrel
TABLET;ORAL-21 074538 ANDA Mayne Pharma Inc. 51862-510 51862-510-06 6 BLISTER PACK in 1 CARTON (51862-510-06) > 1 KIT in 1 BLISTER PACK (51862-510-01)
TRIVORA-21
ethinyl estradiol; levonorgestrel
TABLET;ORAL-21 074538 ANDA Watson Pharma, Inc. 52544-291 52544-291-28 6 BLISTER PACK in 1 CARTON (52544-291-28) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG
Approval Date:Dec 18, 1997TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG
Approval Date:Dec 18, 1997TE:ABRLD:No


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