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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018925
Company: EXELA PHARMA

Products on NDA 018925

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	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018925

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.

Labels for NDA 018925

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

Therapeutic Equivalents for NDA 018925

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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