APPLICATION
ANDA089162
TYPE
ANDA
ORIGINAL APPROVAL
1991-01-24
LATEST ACTION
1996-06-07
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
CYCLOPENTOLATE HYDROCHLORIDEDiscontinued
CYCLOPENTOLATE HYDROCHLORIDE 1% · SOLUTION/DROPS · OPHTHALMIC
Approval history
1996-06-07Manufacturing (CMC) · Supplement 4AP
1996-06-07Manufacturing (CMC) · Supplement 3AP
1996-04-16Manufacturing (CMC) · Supplement 2AP
1994-06-20Labeling · Supplement 1AP
1991-01-24OriginalAP
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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