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FDA ANDA · ANDA087748

BLEPHAMIDE S.O.P.

Sponsor: ALLERGAN

APPLICATION
ANDA087748
TYPE
ANDA
ORIGINAL APPROVAL
1986-12-03
LATEST ACTION
2001-08-15
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

BLEPHAMIDE S.O.P.Discontinued
PREDNISOLONE ACETATE 0.2%, SULFACETAMIDE SODIUM 10% · OINTMENT · OPHTHALMIC

Approval history

2001-08-15Manufacturing (CMC) · Supplement 21AP
2001-08-07Manufacturing (CMC) · Supplement 20AP
2001-08-07Manufacturing (CMC) · Supplement 19AP
2000-12-08Manufacturing (CMC) · Supplement 18AP
1999-11-15Manufacturing (CMC) · Supplement 17AP
1999-09-23Manufacturing (CMC) · Supplement 16AP
1998-11-20Labeling · Supplement 15AP
1998-06-24Manufacturing (CMC) · Supplement 14AP
1998-03-27Manufacturing (CMC) · Supplement 12AP
1998-03-27Manufacturing (CMC) · Supplement 10AP
1998-03-27Manufacturing (CMC) · Supplement 13AP
1998-03-27Manufacturing (CMC) · Supplement 11AP
1996-01-31Manufacturing (CMC) · Supplement 9AP
1995-03-14Labeling · Supplement 8AP
1993-12-02Labeling · Supplement 7AP
1993-06-29Manufacturing (CMC) · Supplement 6AP
1992-07-14Manufacturing (CMC) · Supplement 4AP
1991-01-15Manufacturing (CMC) · Supplement 3AP
1990-03-26Manufacturing (CMC) · Supplement 2AP
1986-12-03OriginalAP
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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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