Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070544
Company: CHARTWELL RX

Products on ANDA 070544

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLDOPA AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METHYLDOPA	50MG;500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070544

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/15/1986	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-27	Labeling-Package Insert		Label is not available on this site.
08/06/2020	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
11/25/1998	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
11/25/1998	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/02/1996	SUPPL-18	Labeling		Label is not available on this site.
08/19/1996	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
01/24/1994	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/02/1993	SUPPL-15	Labeling		Label is not available on this site.
04/30/1993	SUPPL-14	Labeling		Label is not available on this site.
01/31/1992	SUPPL-13	Labeling		Label is not available on this site.
09/15/1989	SUPPL-12	Labeling		Label is not available on this site.
02/17/1988	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
01/29/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/04/1986	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/04/1986	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/11/1986	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.