Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084280
Company: WATSON LABS

Products on ANDA 084280

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084280

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/07/1977	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
07/29/1998	SUPPL-47	Labeling		Label is not available on this site.
02/24/1992	SUPPL-46	Labeling		Label is not available on this site.
11/01/1988	SUPPL-45	Labeling		Label is not available on this site.
01/28/1991	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
08/07/1991	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
11/01/1988	SUPPL-40	Labeling		Label is not available on this site.
03/14/1988	SUPPL-39	Manufacturing (CMC)		Label is not available on this site.
03/14/1988	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
12/18/1985	SUPPL-35	Manufacturing (CMC)		Label is not available on this site.
12/18/1985	SUPPL-34	Manufacturing (CMC)		Label is not available on this site.
12/18/1985	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
06/03/1985	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
06/03/1985	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
12/06/1983	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
01/24/1983	SUPPL-29	Manufacturing (CMC)		Label is not available on this site.