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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075136
Company: HOSPIRA

Products on ANDA 075136

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 075136

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/20/1998	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75136ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75136_Verapamil%20Hydrochloride.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2021	SUPPL-14	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
12/20/2021	SUPPL-12	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 075136

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

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