Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018485
Company: MT ADAMS
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ISOPTIN VERAPAMIL HYDROCHLORIDE 2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
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.

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

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