An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	218813	CIPLA
GLUCAGON	GLUCAGON	1MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	214457	LUPIN LTD
GLUCAGON	GLUCAGON	1MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	204468	MYLAN LABS LTD

Top