FDA ANDA · ANDA072824

BACLOFEN

Sponsor: WATSON LABS

APPLICATION

ANDA072824

TYPE

ANDA

ORIGINAL APPROVAL

1991-09-18

LATEST ACTION

2003-01-02

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

BACLOFENDiscontinued

BACLOFEN 10MG · TABLET · ORAL

2003-01-02Manufacturing (CMC) · Supplement 14AP

2002-05-17Manufacturing (CMC) · Supplement 13AP

2001-04-25Manufacturing (CMC) · Supplement 12AP

2001-03-16Labeling · Supplement 11AP

2001-03-16Manufacturing (CMC) · Supplement 10AP

2000-11-30Manufacturing (CMC) · Supplement 9AP

1999-10-13Manufacturing (CMC) · Supplement 8AP

1999-10-13Manufacturing (CMC) · Supplement 7AP

1999-03-22Manufacturing (CMC) · Supplement 4AP

1998-12-09Manufacturing (CMC) · Supplement 3AP

1992-08-28Manufacturing (CMC) · Supplement 1AP

1991-09-18OriginalAP

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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