• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

  • Print
  • Share
  • E-mail
-

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: N050708
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: N050708
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: N050708
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

Return to Electronic Orange Book Home Page


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 26, 2014

-
-