Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020928
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLUCAGON GLUCAGON 1MG/VIAL INJECTABLE;INJECTION 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
09/11/1998 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20928lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20928ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20928.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/2018 SUPPL-57 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020928Orig1s057Ltr.pdf
07/06/2018 SUPPL-56 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020928s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020928Orig1s056ltr.pdf
04/18/2018 SUPPL-55 Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020928s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020928Orig1s055ltr.pdf
12/18/2015 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

07/21/2015 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

08/11/2014 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

03/27/2014 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

09/27/2013 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

02/24/2004 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20928slr010_glucagon_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20928slr010ltr.pdf
11/15/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

11/12/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1999 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/06/2018 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020928s056lbl.pdf
04/18/2018 SUPPL-55 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020928s055lbl.pdf
04/18/2018 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020928s055lbl.pdf
04/18/2018 SUPPL-55 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020928s055lbl.pdf
02/24/2004 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20928slr010_glucagon_lbl.pdf
09/11/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20928lbl.pdf

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