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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211015
Company: SOMERSET THERAPS LLC

Products on ANDA 211015

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211015

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/18/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/14/2020	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/14/2020	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/14/2020	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211015

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

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	210994	AMNEAL
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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