Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 070098
Company: HERITAGE PHARMA

Products on ANDA 070098

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070098

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/20/1986	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
08/17/2011	SUPPL-58	Labeling		Label is not available on this site.
07/26/2005	SUPPL-52	Labeling		Label is not available on this site.
07/29/2002	SUPPL-47	Manufacturing (CMC)-Facility		Label is not available on this site.
03/08/2002	SUPPL-46	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/12/2001	SUPPL-45	Manufacturing (CMC)-Facility		Label is not available on this site.
07/26/2000	SUPPL-44	Manufacturing (CMC)-Facility		Label is not available on this site.
03/22/2000	SUPPL-43	Labeling		Label is not available on this site.
07/26/2000	SUPPL-42	Manufacturing (CMC)-Facility		Label is not available on this site.
07/26/2000	SUPPL-41	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
07/26/2000	SUPPL-40	Manufacturing (CMC)-Control		Label is not available on this site.
01/18/2000	SUPPL-39	Labeling		Label is not available on this site.
03/28/2000	SUPPL-38	Manufacturing (CMC)-Facility		Label is not available on this site.
03/22/2000	SUPPL-37	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/22/2000	SUPPL-36	Manufacturing (CMC)-Facility		Label is not available on this site.
01/28/2000	SUPPL-35	Manufacturing (CMC)-Facility		Label is not available on this site.
11/23/1999	SUPPL-34	Manufacturing (CMC)-Facility		Label is not available on this site.
08/20/1999	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
01/28/1999	SUPPL-32	Labeling		Label is not available on this site.
07/20/1999	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
12/09/1998	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
05/30/1997	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.
12/10/1996	SUPPL-28	Labeling		Label is not available on this site.
01/06/1997	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
01/06/1997	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
03/13/1996	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
09/01/1993	SUPPL-24	Labeling		Label is not available on this site.
09/18/1992	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
09/18/1992	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
05/18/1992	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
08/12/1991	SUPPL-20	Labeling		Label is not available on this site.
03/08/1989	SUPPL-19	Bioequivalence		Label is not available on this site.
06/10/1988	SUPPL-13	Labeling		Label is not available on this site.
08/30/1988	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
10/20/1987	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
12/29/1987	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/29/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/07/1987	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/10/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.