Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020939
Company: BIOVAIL

Products on NDA 020939

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	240MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	300MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	360MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	420MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020939

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/2000	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20939lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20939ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-939_Diltiazem.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/14/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/17/2000	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020939

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/28/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20939lbl.pdf