Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 084505
Company: SUN PHARM INDUSTRIES

Products on ANDA 084505

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICYCLOMINE HYDROCHLORIDE	DICYCLOMINE HYDROCHLORIDE	10MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084505

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/1975	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
12/01/1998	SUPPL-60	Manufacturing (CMC)		Label is not available on this site.
03/09/1998	SUPPL-59	Labeling		Label is not available on this site.
12/23/1994	SUPPL-58	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-57	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-56	Manufacturing (CMC)		Label is not available on this site.
04/03/1992	SUPPL-54	Manufacturing (CMC)		Label is not available on this site.
12/18/1990	SUPPL-53	Labeling		Label is not available on this site.
10/31/1990	SUPPL-51	Labeling		Label is not available on this site.
06/08/1989	SUPPL-49	Labeling		Label is not available on this site.
03/20/1987	SUPPL-47	Manufacturing (CMC)		Label is not available on this site.
05/15/1986	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
05/15/1986	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
05/15/1986	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
05/15/1986	SUPPL-42	Manufacturing (CMC)		Label is not available on this site.