Is there a generic for Pramlintide acetate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Pramlintide acetate. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Pramlintide acetate?

SYMLIN (NDA 021332, ASTRAZENECA AB) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Pramlintide acetate are approved?

Pramlintide acetate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Pramlintide acetate

Pramlintide acetate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:SYMLIN · NDA 021332

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
SYMLINRLD×3	ASTRAZENECA AB	NDA 021332	—	Sep 25, 2007

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Pramlintide acetate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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