APPLICATION
ANDA070848
TYPE
ANDA
ORIGINAL APPROVAL
1996-03-29
LATEST ACTION
2015-08-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SUCRALFATEPrescription
SUCRALFATE 1GM · TABLET · ORAL
Approval history
2015-08-27Labeling · Supplement 35 · standardAP
2008-09-12Labeling · Supplement 31AP
2007-10-23Labeling · Supplement 27AP
2002-10-23Manufacturing (CMC) · Supplement 17AP
2002-10-23Manufacturing (CMC) · Supplement 18AP
2002-10-23Manufacturing (CMC) · Supplement 16AP
2002-05-15Manufacturing (CMC) · Supplement 15AP
2001-11-13Manufacturing (CMC) · Supplement 13AP
2001-11-13Manufacturing (CMC) · Supplement 14AP
2001-08-30Manufacturing (CMC) · Supplement 12AP
2001-05-29Manufacturing (CMC) · Supplement 10AP
2000-08-24Manufacturing (CMC) · Supplement 9AP
2000-07-07Manufacturing (CMC) · Supplement 8AP
2000-03-31Manufacturing (CMC) · Supplement 7AP
2000-02-16Manufacturing (CMC) · Supplement 6AP
1999-03-26Manufacturing (CMC) · Supplement 5AP
1999-03-12Manufacturing (CMC) · Supplement 4AP
1997-06-18Manufacturing (CMC) · Supplement 3AP
1996-11-08Manufacturing (CMC) · Supplement 1AP
1996-11-08Manufacturing (CMC) · Supplement 2AP
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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