Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075124
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 240MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 180MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None 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
03/18/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75124ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75124ap_appltr_prntlbl_chemr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75124.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/20/2011 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

01/27/2011 SUPPL-16 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

01/27/2005 SUPPL-9 Labeling

Label is not available on this site.

03/24/2004 SUPPL-8 Labeling

Label is not available on this site.

08/07/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/2000 SUPPL-2 Labeling

Label is not available on this site.

02/05/1999 SUPPL-1 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
03/18/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75124ap_appltr_prntlbl_chemr.pdf

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