Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070537
Company: QUAGEN

Products on ANDA 070537

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLDOPA	METHYLDOPA	500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070537

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/02/1987	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
07/26/2024	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
04/11/1996	SUPPL-19	Labeling		Label is not available on this site.
05/18/1994	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/29/1993	SUPPL-17	Labeling		Label is not available on this site.
01/23/1992	SUPPL-16	Labeling		Label is not available on this site.
01/17/1990	SUPPL-14	Bioequivalence		Label is not available on this site.
05/09/1989	SUPPL-10	Labeling		Label is not available on this site.
02/09/1988	SUPPL-9	Labeling		Label is not available on this site.
01/29/1988	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
01/29/1988	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/13/1987	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/13/1987	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/20/1987	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
08/20/1987	SUPPL-3	Labeling		Label is not available on this site.
07/31/1987	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/31/1987	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.