APPLICATION
ANDA080751
TYPE
ANDA
ORIGINAL APPROVAL
1973-12-19
LATEST ACTION
2001-04-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
INFLAMASE MILD · ReferenceDiscontinued
PREDNISOLONE SODIUM PHOSPHATE EQ 0.11% PHOSPHATE · SOLUTION/DROPS · OPHTHALMIC
INFLAMASE FORTE · ReferenceDiscontinued
PREDNISOLONE SODIUM PHOSPHATE EQ 0.9% PHOSPHATE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2001-04-19Manufacturing (CMC) · Supplement 22AP
1996-10-15Manufacturing (CMC) · Supplement 20AP
1996-10-15Labeling · Supplement 21AP
1994-10-26Manufacturing (CMC) · Supplement 18AP
1994-06-10Manufacturing (CMC) · Supplement 19AP
1992-11-02Labeling · Supplement 17AP
1991-04-01Labeling · Supplement 16AP
1989-06-02Manufacturing (CMC) · Supplement 14AP
1989-06-02Manufacturing (CMC) · Supplement 12AP
1989-06-02Labeling · Supplement 10AP
1989-06-02Manufacturing (CMC) · Supplement 15AP
1989-06-02Manufacturing (CMC) · Supplement 13AP
1989-06-02Manufacturing (CMC) · Supplement 11AP
1988-06-17Labeling · Supplement 9AP
1986-08-15Manufacturing (CMC) · Supplement 8AP
1973-12-19OriginalAP
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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