APPLICATION
ANDA074346
TYPE
ANDA
ORIGINAL APPROVAL
1994-06-30
LATEST ACTION
1996-08-27
ROUTE
ORAL
DOSAGE FORM
GRANULE, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
PASERPrescription
AMINOSALICYLIC ACID 4GM/PACKET · GRANULE, DELAYED RELEASE · ORAL
Approval history
1996-08-27Manufacturing (CMC) · Supplement 5AP
1996-08-27Manufacturing (CMC) · Supplement 4AP
1996-08-27Labeling · Supplement 11AP
1996-04-23Manufacturing (CMC) · Supplement 8AP
1996-02-21Manufacturing (CMC) · Supplement 9AP
1995-02-01Manufacturing (CMC) · Supplement 3AP
1995-02-01Manufacturing (CMC) · Supplement 1AP
1995-02-01Manufacturing (CMC) · Supplement 2AP
1994-06-30OriginalAP
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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