Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070265
Company: RISING

Products on ANDA 070265

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLDOPA AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METHYLDOPA	25MG;250MG	TABLET;ORAL	Discontinued	None	No	No
METHYLDOPA AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METHYLDOPA	15MG;250MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070265

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/23/1986	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
08/20/2020	SUPPL-47	Labeling-Package Insert		Label is not available on this site.
12/12/2005	SUPPL-28	Labeling		Label is not available on this site.
09/05/2001	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
05/02/2000	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
11/24/1999	SUPPL-23	Labeling		Label is not available on this site.
01/24/2000	SUPPL-22	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
06/16/1998	SUPPL-21	Labeling		Label is not available on this site.
02/25/1998	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
10/27/1997	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
06/20/1996	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
06/20/1996	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
06/20/1996	SUPPL-16	Labeling		Label is not available on this site.
06/20/1996	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/20/1995	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
10/22/1993	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/29/1993	SUPPL-11	Labeling		Label is not available on this site.
09/26/1991	SUPPL-10	Labeling		Label is not available on this site.
06/20/1991	SUPPL-9	Labeling		Label is not available on this site.
01/31/1990	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/20/1989	SUPPL-7	Labeling		Label is not available on this site.
01/25/1991	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
01/25/1991	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/07/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.