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): 070738
Company: HOSPIRA

Products on ANDA 070738

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070738

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/06/1987	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2021	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
12/20/2021	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
12/09/1998	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/03/1996	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/26/1998	SUPPL-4	Labeling		Label is not available on this site.
04/17/1991	SUPPL-3	Labeling		Label is not available on this site.
02/16/1990	SUPPL-2	Labeling		Label is not available on this site.
05/17/1990	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 070738

VERAPAMIL HYDROCHLORIDE

SOLUTION;INTRAVENOUS; 5MG/2ML (2.5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	210994	AMNEAL
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213232	CAPLIN
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	018925	EXELA PHARMA
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	070737	HOSPIRA
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	070738	HOSPIRA
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	075136	HOSPIRA
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	211370	MICRO LABS
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213352	NEPHRON
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	211035	SOMERSET
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	211015	SOMERSET THERAPS LLC

Top