Details for New Drug Application (NDA): 018977

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NDA 018977 describes TRI-NORINYL 28-DAY, which is a drug marketed by Dr Reddys Labs Sa and is included in one NDA. It is available from one supplier. 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. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for 018977

Tradename:	TRI-NORINYL 28-DAY
Applicant:	Dr Reddys Labs Sa
Ingredient:	ethinyl estradiol; norethindrone
Patents:	0

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 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)
TRI-NORINYL 28-DAY	ethinyl estradiol; norethindrone	TABLET;ORAL-28	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)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL-21			Strength	0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
Approval Date:	Apr 13, 1984	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL-28			Strength	0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
Approval Date:	Apr 13, 1984	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018977

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dr Reddys Labs Sa	TRI-NORINYL 21-DAY	ethinyl estradiol; norethindrone	TABLET;ORAL-21	018977-001	Apr 13, 1984	⤷ Sign Up	⤷ Sign Up
Dr Reddys Labs Sa	TRI-NORINYL 28-DAY	ethinyl estradiol; norethindrone	TABLET;ORAL-28	018977-002	Apr 13, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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