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): 202147
Company: SANDOZ

Products on ANDA 202147

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COSYNTROPIN	COSYNTROPIN	0.25MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202147

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/29/2012	ORIG-1	Approval	Not Applicable		Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202147Orig1s000Approv.pdf

Therapeutic Equivalents for ANDA 202147

COSYNTROPIN

INJECTABLE;INJECTION; 0.25MG/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CORTROSYN	COSYNTROPIN	0.25MG/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	016750	AMPHASTAR PHARMS INC
COSYNTROPIN	COSYNTROPIN	0.25MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	090574	MYLAN INSTITUTIONAL
COSYNTROPIN	COSYNTROPIN	0.25MG/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	202147	SANDOZ

Top