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FDA NDA · NDA050612

PRED-G

Sponsor: ALLERGAN

APPLICATION
NDA050612
TYPE
NDA
ORIGINAL APPROVAL
1989-12-01
LATEST ACTION
2018-06-07
ROUTE
OPHTHALMIC
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

PRED-G · ReferenceDiscontinued
GENTAMICIN SULFATE EQ 0.3% BASE, PREDNISOLONE ACETATE 0.6% · OINTMENT · OPHTHALMIC

Approval history

2018-06-07Labeling · Supplement 21 · standard — Label ↗AP
2017-03-20Labeling · Supplement 20 · standard — Label ↗AP
2003-10-22Manufacturing (CMC) · Supplement 14 · standard — Letter ↗AP
2002-01-28Manufacturing (CMC) · Supplement 13 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 12 · standardAP
2000-10-02Manufacturing (CMC) · Supplement 11 · standardAP
1999-11-09Manufacturing (CMC) · Supplement 10 · standardAP
1999-07-16Manufacturing (CMC) · Supplement 9 · standardAP
1999-04-26Manufacturing (CMC) · Supplement 8 · standardAP
1997-12-29Manufacturing (CMC) · Supplement 7 · standardAP
1997-06-04Manufacturing (CMC) · Supplement 6 · standardAP
1989-12-01Type 3 - New Dosage Form · Original · standardAP
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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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