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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. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the SYMLIN profile page.

The generic ingredient in SYMLIN is pramlintide acetate. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pramlintide acetate profile page.

Summary for NDA: 021332

Tradename:
SYMLIN
Applicant:
Astrazeneca Ab
Ingredient:
pramlintide acetate
Patents:3
Therapeutic Class:Blood Glucose Regulators

Pharmacology for NDA: 021332

Mechanism of ActionAmylin Agonists

Suppliers and Packaging for NDA: 021332

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS 021332 NDA AstraZeneca Pharmaceuticals LP 0310-6615 0310-6615-02 2 CARTRIDGE in 1 CARTON (0310-6615-02) > 1.5 mL in 1 CARTRIDGE
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS 021332 NDA AstraZeneca Pharmaceuticals LP 0310-6627 0310-6627-02 2 CARTRIDGE in 1 CARTON (0310-6627-02) > 2.7 mL in 1 CARTRIDGE

Summary 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
Patent:5,814,600Patent Expiration:Sep 29, 2015Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF A MAMMAL HAVING A NEED OF OR REDUCED ABILITY TO PRODUCE INSULIN WITH AN INSULIN AND AN AMYLIN SUCH AS PRAMLINTIDE
Patent:5,686,411Patent Expiration:Mar 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF DIABETES WITH AN AMYLIN AGONIST, INCLUDING WITH INSULIN
Patent:6,114,304Patent Expiration:Sep 5, 2017Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF AN AMYLIN AGONIST TO REDUCE GASTRIC MOTILITY AND TREAT POST PRANDIAL HYPERGYLCEMIA

Expired Orange Book Patents for NDA: 021332

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-001Mar 16, 20057,407,934► subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 20076,608,029► subscribe
Astrazeneca Ab
SYMLIN
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-002Sep 25, 20075,814,600► subscribe
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