FDA ANDA · ANDA073607

CARBIDOPA AND LEVODOPA

Sponsor: DR REDDYS LABS SA

APPLICATION

ANDA073607

TYPE

ANDA

ORIGINAL APPROVAL

1992-08-28

LATEST ACTION

2015-11-05

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Prescription

Products

CARBIDOPA AND LEVODOPAPrescription

CARBIDOPA 25MG, LEVODOPA 250MG · TABLET · ORAL

2015-11-05Labeling · Supplement 28 · standardAP

2011-07-05Labeling · Supplement 27AP

2011-02-03Manufacturing (CMC) · Supplement 26AP

2009-10-30Labeling · Supplement 23AP

2007-03-26Labeling · Supplement 18AP

2002-01-04Manufacturing (CMC) · Supplement 14AP

2002-01-04Manufacturing (CMC) · Supplement 13AP

2001-11-06Labeling · Supplement 15AP

1999-12-02Manufacturing (CMC) · Supplement 10AP

1999-12-02Manufacturing (CMC) · Supplement 11AP

1999-02-12Manufacturing (CMC) · Supplement 4AP

1999-02-12Manufacturing (CMC) · Supplement 5AP

1997-10-28Manufacturing (CMC) · Supplement 3AP

1996-12-27Manufacturing (CMC) · Supplement 2AP

1996-08-27Manufacturing (CMC) · Supplement 1AP

1992-08-28OriginalAP

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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