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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070737
Company: HOSPIRA

Products on ANDA 070737

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
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070737

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
09/09/2024	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/070737Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/070737Orig1s028ltr.pdf
12/20/2021	SUPPL-25	Labeling-Container/Carton Labels		Label is not available on this site.
10/25/2002	SUPPL-13	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/22/2001	SUPPL-12	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/22/2001	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/07/2000	SUPPL-10	Labeling		Label is not available on this site.
01/07/2000	SUPPL-9	Manufacturing (CMC)-Microbiology-Processing		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.
10/22/1996	SUPPL-5	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/26/1998	SUPPL-3	Labeling		Label is not available on this site.
04/17/1991	SUPPL-2	Labeling		Label is not available on this site.
05/17/1990	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 070737

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/09/2024	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/070737Orig1s028lbl.pdf

Therapeutic Equivalents for ANDA 070737

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	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

SOLUTION;INTRAVENOUS; 10MG/4ML (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	10MG/4ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213232	CAPLIN
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	070737	HOSPIRA
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	211370	MICRO LABS
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	213352	NEPHRON
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	211035	SOMERSET
VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	211015	SOMERSET THERAPS LLC

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