APPLICATION
ANDA064134
TYPE
ANDA
ORIGINAL APPROVAL
1999-10-27
LATEST ACTION
2023-07-21
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription
Products
TOBRAMYCIN AND DEXAMETHASONEPrescription
DEXAMETHASONE 0.1%, TOBRAMYCIN 0.3% · SUSPENSION/DROPS · OPHTHALMIC
Approval history
2023-07-21Labeling · Supplement 29 · standardAP
2023-07-21Labeling · Supplement 25 · standardAP
2008-11-06Labeling · Supplement 9AP
2002-02-05Manufacturing (CMC) · Supplement 7AP
2001-11-27Manufacturing (CMC) · Supplement 6AP
2001-03-07Manufacturing (CMC) · Supplement 4AP
2000-08-21Manufacturing (CMC) · Supplement 2AP
2000-07-20Manufacturing (CMC) · Supplement 1AP
2000-06-27Manufacturing (CMC) · Supplement 3AP
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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