Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210994
Company: AMNEAL
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/13/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

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 018925 EXELA PHARMA SCS LLC
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 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 018925 EXELA PHARMA SCS LLC
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 211035 SOMERSET
VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 211015 SOMERSET THERAPS LLC

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