Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208086
Company: AMPHASTAR PHARMS INC

Products on ANDA 208086

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLUCAGON	GLUCAGON	1MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208086

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/28/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208086Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 208086

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	No	AP	204468	MYLAN LABS LTD