APPLICATION
ANDA040164
TYPE
ANDA
ORIGINAL APPROVAL
1997-01-13
LATEST ACTION
2017-07-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
AKPENTOLATEPrescription
CYCLOPENTOLATE HYDROCHLORIDE 1% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2017-07-19Labeling · Supplement 8 · standardAP
2015-04-13Labeling · Supplement 6AP
2012-07-25Labeling · Supplement 7AP
2001-10-09Manufacturing (CMC) · Supplement 3AP
2001-10-09Manufacturing (CMC) · Supplement 4AP
2001-07-11Manufacturing (CMC) · Supplement 2AP
1999-06-07Manufacturing (CMC) · Supplement 1AP
1997-01-13OriginalAP
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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