Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021332
Company: ASTRAZENECA AB
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
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
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-Container/Carton Labels, Labeling-Package Insert 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021332s006lbl.pdf
09/25/2007 SUPPL-6 Labeling-Package Insert 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

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