Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072838
Company: RISING

Products on ANDA 072838

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	120MG	TABLET;ORAL	Discontinued	None	No	No
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	90MG	TABLET;ORAL	Discontinued	None	No	No
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	60MG	TABLET;ORAL	Discontinued	None	No	No
DILTIAZEM HYDROCHLORIDE	DILTIAZEM HYDROCHLORIDE	30MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072838

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
05/21/2020	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
04/08/2020	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
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.