Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072838
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET;ORAL Prescription AB No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Prescription AB No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Prescription AB No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Prescription AB 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
11/05/1992 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/29/2011 SUPPL-19 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/12/2007 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/12/1996 SUPPL-6 Labeling

Label is not available on this site.

07/13/1995 SUPPL-5 Labeling

Label is not available on this site.

08/29/1995 SUPPL-4 Labeling

Label is not available on this site.

08/29/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/13/1993 SUPPL-2 Labeling

Label is not available on this site.

DILTIAZEM HYDROCHLORIDE

TABLET;ORAL; 120MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM DILTIAZEM HYDROCHLORIDE 120MG TABLET;ORAL Prescription Yes AB 018602 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 072838 MYLAN
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET;ORAL Prescription No AB 074185 TEVA

TABLET;ORAL; 90MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Prescription Yes AB 018602 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Prescription No AB 072838 MYLAN
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Prescription No AB 074185 TEVA

TABLET;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Prescription Yes AB 018602 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 072838 MYLAN
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 074185 TEVA

TABLET;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CARDIZEM DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Prescription Yes AB 018602 BAUSCH
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 072838 MYLAN
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Prescription No AB 074185 TEVA

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