Details for New Drug Application (NDA): 203696

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NDA 203696 describes LUPANETA PACK, which is a drug marketed by Abbvie Endocrine and is included in one NDA. Additional details are available on the LUPANETA PACK profile page.

The generic ingredient in LUPANETA PACK is leuprolide acetate; norethindrone acetate. There are twenty-two drug master file entries for this compound. Additional details are available on the leuprolide acetate; norethindrone acetate profile page.

Summary for 203696

Tradename:	LUPANETA PACK
Applicant:	Abbvie Endocrine
Ingredient:	leuprolide acetate; norethindrone acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL			Strength	3.75MG/VIAL,N/A;N/A,5MG
Approval Date:	Dec 14, 2012	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL			Strength	11.25MG/VIAL,N/A;N/A,5MG
Approval Date:	Dec 14, 2012	TE:		RLD:	Yes

Expired US Patents for NDA 203696

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Endocrine	LUPANETA PACK	leuprolide acetate; norethindrone acetate	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	203696-001	Dec 14, 2012	⤷ Sign Up	⤷ Sign Up
Abbvie Endocrine	LUPANETA PACK	leuprolide acetate; norethindrone acetate	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	203696-002	Dec 14, 2012	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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