Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070288
Company: ACTAVIS MID ATLANTIC

Products on ANDA 070288

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CONSTULOSE	LACTULOSE	10GM/15ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070288

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/15/1988	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
12/16/1997	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
08/26/1996	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
01/17/1996	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
09/09/1994	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
06/04/1993	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
08/03/1993	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
06/04/1993	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
07/24/1991	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
02/11/1993	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
02/21/1991	SUPPL-15	Labeling		Label is not available on this site.
09/28/1990	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
01/27/1992	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/31/1990	SUPPL-12	Labeling		Label is not available on this site.
08/21/1991	SUPPL-9	Labeling		Label is not available on this site.
08/19/1988	SUPPL-1	Labeling		Label is not available on this site.