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Generated: December 15, 2017

DrugPatentWatch Database Preview

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 one supplier. There are two 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. One supplier is listed for this compound. Additional details are available on the pramlintide acetate profile page.

Summary for 021332

Tradename:1
Applicant:1
Ingredient:1
Patents:2
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:► SubscribePatent Expiration:Mar 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF DIABETES WITH AN AMYLIN AGONIST, INCLUDING WITH INSULIN
Patent:► SubscribePatent 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

Summary 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
Patent:► SubscribePatent Expiration:Mar 16, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF DIABETES WITH AN AMYLIN AGONIST, INCLUDING WITH INSULIN

Expired Orange Book Patents for NDA: 021332

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-002Sep 25, 2007► Subscribe► Subscribe
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005► Subscribe► Subscribe
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-002Sep 25, 2007► Subscribe► Subscribe
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007► Subscribe► Subscribe
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005► Subscribe► Subscribe
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007► Subscribe► Subscribe
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007► Subscribe► Subscribe
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005► Subscribe► Subscribe
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-001Mar 16, 2005► Subscribe► Subscribe
Astrazeneca AbSYMLINpramlintide acetateINJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007► Subscribe► Subscribe
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