Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021332

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SYMLIN (PRAMLINTIDE ACETATE)
EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) Marketing Status: Prescription

Active Ingredient: PRAMLINTIDE ACETATE
Proprietary Name: SYMLIN
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021332
Product Number: 002
Approval Date: Sep 25, 2007
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information

SYMLIN (PRAMLINTIDE ACETATE)
EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) Marketing Status: Prescription

Active Ingredient: PRAMLINTIDE ACETATE
Proprietary Name: SYMLIN
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021332
Product Number: 003
Approval Date: Sep 25, 2007
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information

SYMLIN (PRAMLINTIDE ACETATE)
EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) Marketing Status: Discontinued

Active Ingredient: PRAMLINTIDE ACETATE
Proprietary Name: SYMLIN
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021332
Product Number: 001
Approval Date: Mar 16, 2005
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Discontinued
Patent and Exclusivity Information

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