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Drugs@FDA: FDA-Approved Drugs

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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
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
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