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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "020263."



Active Ingredient: LEUPROLIDE ACETATE
Dosage Form;Route: INJECTABLE;INJECTION
Proprietary Name: LUPRON DEPOT-PED
Applicant: ABBVIE ENDOCRINE INC
Strength: 7.5MG/VIAL
Application Number: N020263
Product Number: 002
Approval Date: Apr 16, 1993
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: LEUPROLIDE ACETATE
Dosage Form;Route: INJECTABLE;INJECTION
Proprietary Name: LUPRON DEPOT-PED
Applicant: ABBVIE ENDOCRINE INC
Strength: 11.25MG/VIAL
Application Number: N020263
Product Number: 005
Approval Date: Jan 21, 1994
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: LEUPROLIDE ACETATE
Dosage Form;Route: INJECTABLE;INJECTION
Proprietary Name: LUPRON DEPOT-PED
Applicant: ABBVIE ENDOCRINE INC
Strength: 15MG/VIAL
Application Number: N020263
Product Number: 006
Approval Date: Jan 21, 1994
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: LEUPROLIDE ACETATE
Dosage Form;Route: INJECTABLE;INJECTION
Proprietary Name: LUPRON DEPOT-PED
Applicant: ABBVIE ENDOCRINE INC
Strength: 11.25MG/VIAL
Application Number: N020263
Product Number: 007
Approval Date: Aug 15, 2011
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: LEUPROLIDE ACETATE
Dosage Form;Route: INJECTABLE;INJECTION
Proprietary Name: LUPRON DEPOT-PED
Applicant: ABBVIE ENDOCRINE INC
Strength: 30MG/VIAL
Application Number: N020263
Product Number: 008
Approval Date: Aug 15, 2011
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through October 2014
Patent and Generic Drug Product Data Last Updated November 28, 2014

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