Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018485
Company: MT ADAMS

Products on NDA 018485

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOPTIN	VERAPAMIL HYDROCHLORIDE	2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018485

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/12/1981	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/1998	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/07/1994	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/018485s009lbl.pdf
09/16/1992	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/08/1986	SUPPL-7	Labeling		Label is not available on this site.
12/18/1985	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
08/21/1984	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/16/1987	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/12/1984	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
04/12/1984	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018485

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/07/1994	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/018485s009lbl.pdf