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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020928
Company: LILLY

Products on NDA 020928

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLUCAGON	GLUCAGON	1MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020928

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
01/26/2021	SUPPL-60	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020928s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020928Orig1s060ltr.pdf
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-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert	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.

Labels for NDA 020928

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/26/2021	SUPPL-60	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020928s060lbl.pdf
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-Container/Carton Labels	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-Patient Package Insert	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

Therapeutic Equivalents for NDA 020928

GLUCAGON

INJECTABLE;INJECTION; 1MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GLUCAGON	GLUCAGON	1MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	208086	AMPHASTAR PHARMS INC
GLUCAGON	GLUCAGON	1MG/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	020928	LILLY

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