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Serving leading biopharmaceutical companies globally:

Harvard Business School
Farmers Insurance

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018977

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NDA 018977 describes TRI-NORINYL 28-DAY, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from two suppliers. Additional details are available on the TRI-NORINYL 28-DAY profile page.

The generic ingredient in TRI-NORINYL 28-DAY is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for 018977

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 018977

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRI-NORINYL 21-DAY ethinyl estradiol; norethindrone TABLET;ORAL-21 018977 NDA Mayne Pharma Inc. 51862-470 51862-470-06 6 BLISTER PACK in 1 CARTON (51862-470-06) > 1 KIT in 1 BLISTER PACK (51862-470-01)
TRI-NORINYL 21-DAY ethinyl estradiol; norethindrone TABLET;ORAL-21 018977 NDA AUTHORIZED GENERIC Mayne Pharma Inc. 51862-471 51862-471-06 6 BLISTER PACK in 1 CARTON (51862-471-06) > 1 KIT in 1 BLISTER PACK (51862-471-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
Approval Date:Apr 13, 1984TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
Approval Date:Apr 13, 1984TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 018977

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mayne PharmaTRI-NORINYL 21-DAYethinyl estradiol; norethindroneTABLET;ORAL-21018977-001Apr 13, 1984► Subscribe► Subscribe
Mayne PharmaTRI-NORINYL 28-DAYethinyl estradiol; norethindroneTABLET;ORAL-28018977-002Apr 13, 1984► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Queensland Health
Johnson and Johnson
Federal Trade Commission

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