← FDA DRUG APPROVALS

FDA NDA · NDA021332

SYMLINPEN

pramlintide acetate

Sponsor: ASTRAZENECA AB

APPLICATION
NDA021332
TYPE
NDA
ORIGINAL APPROVAL
2005-03-16
LATEST ACTION
2019-12-18
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

SYMLIN · ReferenceDiscontinued
PRAMLINTIDE ACETATE EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) · INJECTABLE · SUBCUTANEOUS
SYMLIN · ReferenceDiscontinued
PRAMLINTIDE ACETATE EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) · INJECTABLE · SUBCUTANEOUS
SYMLINDiscontinued
PRAMLINTIDE ACETATE EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) · INJECTABLE · SUBCUTANEOUS

Approval history

2019-12-18Labeling · Supplement 28 · standard — Label ↗AP
2017-03-08REMS · Supplement 26 — Letter ↗AP
2015-08-07REMS · Supplement 24 — Letter ↗AP
2015-03-20Labeling · Supplement 25 · standard — Letter ↗AP
2015-02-25Labeling · Supplement 23 · 901 required — Letter ↗AP
2014-06-27Efficacy · Supplement 7 · unknown — Letter ↗AP
2014-06-27Labeling · Supplement 16 · standard — Letter ↗AP
2012-01-03Labeling · Supplement 20 · standard — Letter ↗AP
2008-08-04Labeling · Supplement 10 · standard — Letter ↗AP
2007-09-25Manufacturing (CMC) · Supplement 6 — Letter ↗AP
2005-03-16Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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