Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018593
Company: MT ADAMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOPTIN VERAPAMIL HYDROCHLORIDE 80MG TABLET;ORAL Discontinued None Yes No
ISOPTIN VERAPAMIL HYDROCHLORIDE 120MG TABLET;ORAL Discontinued None Yes No
ISOPTIN VERAPAMIL HYDROCHLORIDE 40MG TABLET;ORAL 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
03/08/1982 ORIG-1 Approval Type 3 - New Dosage Form 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
09/14/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/20/1988 SUPPL-14 Labeling

Label is not available on this site.

06/22/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/23/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/28/1987 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/15/1988 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

09/10/1984 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/10/1984 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/16/1986 SUPPL-6 Efficacy-New Indication

Label is not available on this site.

12/16/1986 SUPPL-4 Efficacy-New Indication

Label is not available on this site.

07/27/1982 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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