Search results from the "OB_Rx" table for query on "050708."



Active Ingredient: TACROLIMUS
Dosage Form;Route: CAPSULE; ORAL
Proprietary Name: PROGRAF
Applicant: ASTELLAS
Strength: EQ 1MG BASE
Application Number: 050708
Product Number: 001
Approval Date: Apr 8, 1994
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: TACROLIMUS
Dosage Form;Route: CAPSULE; ORAL
Proprietary Name: PROGRAF
Applicant: ASTELLAS
Strength: EQ 5MG BASE
Application Number: 050708
Product Number: 002
Approval Date: Apr 8, 1994
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: TACROLIMUS
Dosage Form;Route: CAPSULE; ORAL
Proprietary Name: PROGRAF
Applicant: ASTELLAS
Strength: EQ 0.5MG BASE
Application Number: 050708
Product Number: 003
Approval Date: Aug 24, 1998
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
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
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    Orange Book Data Updated Through October, 2009
    Patent and Generic Drug Product Data Last Updated: November 20, 2009