Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074425
Company: RISING

Products on ANDA 074425

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENTOXIFYLLINE	PENTOXIFYLLINE	400MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074425

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/08/1997	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
11/02/2020	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
01/21/2016	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
01/21/2016	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
12/12/2005	SUPPL-14	Labeling		Label is not available on this site.
01/12/2007	SUPPL-13	Manufacturing (CMC)-Facility		Label is not available on this site.
01/21/2004	SUPPL-11	Labeling		Label is not available on this site.
04/19/2000	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
11/15/1999	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
11/03/1999	SUPPL-8	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
11/03/1999	SUPPL-7	Labeling		Label is not available on this site.
11/03/1999	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/22/1999	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/25/1998	SUPPL-4	Labeling		Label is not available on this site.
04/07/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
04/07/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/26/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.