Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203696

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LUPANETA PACK (LEUPROLIDE ACETATE; NORETHINDRONE ACETATE)
3.75MG/VIAL,N/A;N/A,5MG
Marketing Status: Discontinued

Active Ingredient: LEUPROLIDE ACETATE; NORETHINDRONE ACETATE
Proprietary Name: LUPANETA PACK
Dosage Form; Route of Administration: INJECTABLE, TABLET; INTRAMUSCULAR, ORAL
Strength: 3.75MG/VIAL,N/A;N/A,5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203696
Product Number: 001
Approval Date: Dec 14, 2012
Applicant Holder Full Name: ABBVIE ENDOCRINE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

LUPANETA PACK (LEUPROLIDE ACETATE; NORETHINDRONE ACETATE)
11.25MG/VIAL,N/A;N/A,5MG
Marketing Status: Discontinued

Active Ingredient: LEUPROLIDE ACETATE; NORETHINDRONE ACETATE
Proprietary Name: LUPANETA PACK
Dosage Form; Route of Administration: INJECTABLE, TABLET; INTRAMUSCULAR, ORAL
Strength: 11.25MG/VIAL,N/A;N/A,5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203696
Product Number: 002
Approval Date: Dec 14, 2012
Applicant Holder Full Name: ABBVIE ENDOCRINE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information