• 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 "020287."



Active Ingredient: DALTEPARIN SODIUM
Dosage Form;Route: INJECTABLE;SUBCUTANEOUS
Proprietary Name: FRAGMIN
Applicant: EISAI INC
Strength: 2,500IU/0.2ML (12,500IU/ML)
Application Number: N020287
Product Number: 001
Approval Date: Dec 22, 1994
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: DALTEPARIN SODIUM
Dosage Form;Route: INJECTABLE;SUBCUTANEOUS
Proprietary Name: FRAGMIN
Applicant: EISAI INC
Strength: 5,000IU/0.2ML (25,000IU/ML)
Application Number: N020287
Product Number: 003
Approval Date: Mar 18, 1996
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: DALTEPARIN SODIUM
Dosage Form;Route: INJECTABLE;SUBCUTANEOUS
Proprietary Name: FRAGMIN
Applicant: EISAI INC
Strength: 10,000IU/ML (10,000IU/ML)
Application Number: N020287
Product Number: 004
Approval Date: Jan 30, 1998
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: DALTEPARIN SODIUM
Dosage Form;Route: INJECTABLE;SUBCUTANEOUS
Proprietary Name: FRAGMIN
Applicant: EISAI INC
Strength: 7,500IU/0.3ML (25,000IU/ML)
Application Number: N020287
Product Number: 005
Approval Date: Apr 4, 2002
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: DALTEPARIN SODIUM
Dosage Form;Route: INJECTABLE;SUBCUTANEOUS
Proprietary Name: FRAGMIN
Applicant: EISAI INC
Strength: 95,000IU/3.8ML (25,000IU/ML)
Application Number: N020287
Product Number: 006
Approval Date: Apr 4, 2002
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: DALTEPARIN SODIUM
Dosage Form;Route: INJECTABLE;SUBCUTANEOUS
Proprietary Name: FRAGMIN
Applicant: EISAI INC
Strength: 12,500IU/0.5ML (25,000IU/ML)
Application Number: N020287
Product Number: 009
Approval Date: May 1, 2007
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: DALTEPARIN SODIUM
Dosage Form;Route: INJECTABLE;SUBCUTANEOUS
Proprietary Name: FRAGMIN
Applicant: EISAI INC
Strength: 15,000IU/0.6ML (25,000IU/ML)
Application Number: N020287
Product Number: 010
Approval Date: May 1, 2007
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: DALTEPARIN SODIUM
Dosage Form;Route: INJECTABLE;SUBCUTANEOUS
Proprietary Name: FRAGMIN
Applicant: EISAI INC
Strength: 18,000IU/0.72ML (25,000IU/ML)
Application Number: N020287
Product Number: 011
Approval Date: May 1, 2007
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
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 June 2014
Patent and Generic Drug Product Data Last Updated July 25, 2014

-
-