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FDA ANDA · ANDA084300
CYCLOMYDRIL
cyclopentolate hydrochloride and phenylephrine hydrochloride
Sponsor: ALCON LABS INC
APPLICATION
ANDA084300
TYPE
ANDA
ORIGINAL APPROVAL
1975-09-12
LATEST ACTION
2025-05-02
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
CYCLOMYDRIL · ReferencePrescription
CYCLOPENTOLATE HYDROCHLORIDE 0.2%, PHENYLEPHRINE HYDROCHLORIDE 1% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2025-05-02Labeling · Supplement 44 · standardAP
2003-10-31Labeling · Supplement 32AP
2002-12-23Manufacturing (CMC) · Supplement 29AP
2002-12-19Manufacturing (CMC) · Supplement 30AP
2001-04-18Manufacturing (CMC) · Supplement 27AP
2001-04-18Manufacturing (CMC) · Supplement 25AP
2001-04-18Manufacturing (CMC) · Supplement 26AP
2001-04-18Manufacturing (CMC) · Supplement 24AP
2000-04-28Manufacturing (CMC) · Supplement 23AP
2000-04-07Manufacturing (CMC) · Supplement 28AP
1999-05-07Manufacturing (CMC) · Supplement 21AP
1999-03-23Manufacturing (CMC) · Supplement 22AP
1999-03-04Manufacturing (CMC) · Supplement 20AP
1996-12-24Labeling · Supplement 11AP
1996-12-24Labeling · Supplement 14AP
1996-04-03Manufacturing (CMC) · Supplement 17AP
1996-03-18Manufacturing (CMC) · Supplement 19AP
1996-03-18Manufacturing (CMC) · Supplement 18AP
1995-10-05Manufacturing (CMC) · Supplement 16AP
1994-08-04Manufacturing (CMC) · Supplement 15AP
1993-06-04Manufacturing (CMC) · Supplement 12AP
1993-06-04Manufacturing (CMC) · Supplement 10AP
1992-11-05Manufacturing (CMC) · Supplement 13AP
1989-03-24Labeling · Supplement 9AP
1989-03-09Manufacturing (CMC) · Supplement 6AP
1985-12-17Manufacturing (CMC) · Supplement 4AP
1975-09-12OriginalAP
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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