An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021332
Company: ASTRAZENECA AB

Medication Guide

Products on NDA 021332

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SYMLIN	PRAMLINTIDE ACETATE	EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Discontinued	None	No	No
SYMLIN	PRAMLINTIDE ACETATE	EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	None	Yes	No
SYMLIN	PRAMLINTIDE ACETATE	EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021332

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/16/2005	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021332lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021332ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-332_Symlin.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2019	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021332s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021332Orig1s028ltr.pdf
03/08/2017	SUPPL-26	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021332Orig1s026ltr.pdf
03/20/2015	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021332s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021332Orig1s025ltr.pdf
08/07/2015	SUPPL-24	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021332Orig1s024ltr.pdf
02/25/2015	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021332s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021332Orig1s023ltr.pdf
01/03/2012	SUPPL-20	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021332s020ltr.pdf
06/27/2014	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021332s007_S016.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021332Orig1s007,s016ltr.pdf
08/04/2008	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021332s010ltr.pdf
06/27/2014	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021332s007_S016.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021332Orig1s007,s016ltr.pdf
09/25/2007	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021332s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021332s006ltr.pdf

Labels for NDA 021332

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2019	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021332s028lbl.pdf
03/20/2015	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021332s025lbl.pdf
02/25/2015	SUPPL-23	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021332s023lbl.pdf
06/27/2014	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021332s007_S016.pdf
06/27/2014	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021332s007_S016.pdf
09/25/2007	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021332s006lbl.pdf
09/25/2007	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021332s006lbl.pdf
03/16/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021332lbl.pdf

Top