Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018925
Company: EXELA PHARMA SCS LLC
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
03/30/1984 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
11/18/2016 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018925s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018925Orig1s010ltr.pdf
04/08/2016 SUPPL-9 Labeling-Container/Carton Labels

Label is not available on this site.

11/02/2011 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018925s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018925s008ltr.pdf
04/13/2010 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018925s007,019038s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018925s007,019038s003ltr.pdf
10/25/1988 SUPPL-6 Labeling

Label is not available on this site.

09/15/1986 SUPPL-5 Labeling

Label is not available on this site.

09/16/1986 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1986 SUPPL-3 Labeling

Label is not available on this site.

02/21/1985 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/18/2016 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018925s010lbl.pdf
11/02/2011 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018925s008lbl.pdf
04/13/2010 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018925s007,019038s003lbl.pdf

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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