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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. Twenty-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for NDA: 018977

Mayne Pharma
ethinyl estradiol; norethindrone

Suppliers and Packaging for NDA: 018977

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)
ethinyl estradiol; norethindrone
TABLET;ORAL-21 018977 ANDA 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

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mayne Pharma
ethinyl estradiol; norethindrone
TABLET;ORAL-21018977-001Apr 13, 19844,390,531<subscribe>
Mayne Pharma
ethinyl estradiol; norethindrone
TABLET;ORAL-28018977-002Apr 13, 19844,390,531<subscribe>
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