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. 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. One supplier is listed 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

Pharmacology for NDA: 021332

Mechanism of Action	Amylin 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

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

Expired US Patents for NDA 021332

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-001	Mar 16, 2005	6,610,824	⤷ Subscribe
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-003	Sep 25, 2007	5,814,600	⤷ Subscribe
Astrazeneca Ab	SYMLIN	pramlintide acetate	INJECTABLE;SUBCUTANEOUS	021332-001	Mar 16, 2005	5,175,145	⤷ Subscribe
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