FDA ANDA · ANDA071548

ENULOSE

Sponsor: ACTAVIS MID ATLANTIC

APPLICATION

ANDA071548

TYPE

ANDA

ORIGINAL APPROVAL

1988-08-15

LATEST ACTION

2009-12-20

ROUTE

ORAL, RECTAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

ENULOSEDiscontinued

LACTULOSE 10GM/15ML · SOLUTION · ORAL, RECTAL

2009-12-20Labeling · Supplement 38AP

1998-08-07Manufacturing (CMC) · Supplement 24AP

1996-08-19Manufacturing (CMC) · Supplement 22AP

1994-09-09Manufacturing (CMC) · Supplement 21AP

1993-08-03Manufacturing (CMC) · Supplement 20AP

1993-06-11Manufacturing (CMC) · Supplement 18AP

1993-06-11Manufacturing (CMC) · Supplement 19AP

1993-02-08Manufacturing (CMC) · Supplement 16AP

1992-04-06Manufacturing (CMC) · Supplement 14AP

1991-10-16Manufacturing (CMC) · Supplement 12AP

1990-09-28Manufacturing (CMC) · Supplement 15AP

1990-07-31Labeling · Supplement 13AP

1988-12-15Manufacturing (CMC) · Supplement 2AP

1988-08-15OriginalAP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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