Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074093
Company: CHARTWELL MOLECULES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 30MG TABLET;ORAL Discontinued None No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG TABLET;ORAL Discontinued None No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG TABLET;ORAL Discontinued None No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG TABLET;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
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
10/04/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/29/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/28/1997 SUPPL-12 Labeling

Label is not available on this site.

01/16/1997 SUPPL-11 Labeling

Label is not available on this site.

12/11/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/29/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/15/1995 SUPPL-8 Labeling

Label is not available on this site.

11/07/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/07/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/08/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/23/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/23/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/28/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/10/1994 SUPPL-1 Labeling

Label is not available on this site.

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