Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020287

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FRAGMIN (DALTEPARIN SODIUM)
2,500IU/0.2ML (12,500IU/ML)
Marketing Status: Prescription

Active Ingredient: DALTEPARIN SODIUM
Proprietary Name: FRAGMIN
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 2,500IU/0.2ML (12,500IU/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020287
Product Number: 001
Approval Date: Dec 22, 1994
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FRAGMIN (DALTEPARIN SODIUM)
5,000IU/0.2ML (25,000IU/ML)
Marketing Status: Prescription

Active Ingredient: DALTEPARIN SODIUM
Proprietary Name: FRAGMIN
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 5,000IU/0.2ML (25,000IU/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020287
Product Number: 003
Approval Date: Mar 18, 1996
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FRAGMIN (DALTEPARIN SODIUM)
7,500IU/0.3ML (25,000IU/ML)
Marketing Status: Prescription

Active Ingredient: DALTEPARIN SODIUM
Proprietary Name: FRAGMIN
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 7,500IU/0.3ML (25,000IU/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020287
Product Number: 005
Approval Date: Apr 4, 2002
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FRAGMIN (DALTEPARIN SODIUM)
10,000IU/ML (10,000IU/ML)
Marketing Status: Prescription

Active Ingredient: DALTEPARIN SODIUM
Proprietary Name: FRAGMIN
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 10,000IU/ML (10,000IU/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020287
Product Number: 004
Approval Date: Jan 30, 1998
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FRAGMIN (DALTEPARIN SODIUM)
10,000IU/4ML (2,500IU/ML)
Marketing Status: Prescription

Active Ingredient: DALTEPARIN SODIUM
Proprietary Name: FRAGMIN
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 10,000IU/4ML (2,500IU/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020287
Product Number: 012
Approval Date: Mar 15, 2022
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FRAGMIN (DALTEPARIN SODIUM)
12,500IU/0.5ML (25,000IU/ML)
Marketing Status: Prescription

Active Ingredient: DALTEPARIN SODIUM
Proprietary Name: FRAGMIN
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 12,500IU/0.5ML (25,000IU/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020287
Product Number: 009
Approval Date: May 1, 2007
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FRAGMIN (DALTEPARIN SODIUM)
15,000IU/0.6ML (25,000IU/ML)
Marketing Status: Prescription

Active Ingredient: DALTEPARIN SODIUM
Proprietary Name: FRAGMIN
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 15,000IU/0.6ML (25,000IU/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020287
Product Number: 010
Approval Date: May 1, 2007
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FRAGMIN (DALTEPARIN SODIUM)
18,000IU/0.72ML (25,000IU/ML)
Marketing Status: Prescription

Active Ingredient: DALTEPARIN SODIUM
Proprietary Name: FRAGMIN
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 18,000IU/0.72ML (25,000IU/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020287
Product Number: 011
Approval Date: May 1, 2007
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FRAGMIN (DALTEPARIN SODIUM)
95,000IU/3.8ML (25,000IU/ML)
Marketing Status: Prescription

Active Ingredient: DALTEPARIN SODIUM
Proprietary Name: FRAGMIN
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 95,000IU/3.8ML (25,000IU/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020287
Product Number: 006
Approval Date: Apr 4, 2002
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FRAGMIN (DALTEPARIN SODIUM)
7,500 IU/0.75ML
Marketing Status: Discontinued

Active Ingredient: DALTEPARIN SODIUM
Proprietary Name: FRAGMIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 7,500 IU/0.75ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020287
Product Number: 008
Approval Date: Apr 4, 2002
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

FRAGMIN (DALTEPARIN SODIUM)
10,000IU/0.4ML (25,000IU/ML)
Marketing Status: Discontinued

Active Ingredient: DALTEPARIN SODIUM
Proprietary Name: FRAGMIN
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 10,000IU/0.4ML (25,000IU/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020287
Product Number: 002
Approval Date: May 1, 2007
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

FRAGMIN (DALTEPARIN SODIUM)
95,000IU/9.5ML (10,000IU/ML)
Marketing Status: Discontinued

Active Ingredient: DALTEPARIN SODIUM
Proprietary Name: FRAGMIN
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 95,000IU/9.5ML (10,000IU/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020287
Product Number: 007
Approval Date: Apr 4, 2002
Applicant Holder Full Name: PFIZER INC
Marketing Status:  Discontinued
Patent and Exclusivity Information