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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 021332


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NDA 021332 describes SYMLIN, which is a drug marketed by Astrazeneca Ab and is included in one NDA. Additional details are available on the SYMLIN profile page.

The generic ingredient in SYMLIN is pramlintide acetate. There are three drug master file entries for this compound. Additional details are available on the pramlintide acetate profile page.
Summary for 021332
Tradename:SYMLIN
Applicant:Astrazeneca Ab
Ingredient:pramlintide acetate
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 3MG BASE/5ML (EQ 600MCG BASE/ML)
Approval Date:Mar 16, 2005TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)
Approval Date:Sep 25, 2007TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrengthEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)
Approval Date:Sep 25, 2007TE:RLD:Yes

Expired US Patents for NDA 021332

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-003 Sep 25, 2007 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-001 Mar 16, 2005 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-003 Sep 25, 2007 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-002 Sep 25, 2007 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab SYMLIN pramlintide acetate INJECTABLE;SUBCUTANEOUS 021332-003 Sep 25, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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