Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074845
Company: BIOVAIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 90MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DILTIAZEM HYDROCHLORIDE DILTIAZEM HYDROCHLORIDE 120MG 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
09/15/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74845_Diltiazem_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74845ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74-845_Diltiazem.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/15/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74845_Diltiazem_prntlbl.pdf

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