Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204059
Company: BAYSHORE PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KETOTIFEN FUMARATE KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/01/2020 ORIG-1 Approval

Label is not available on this site.

KETOTIFEN FUMARATE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SOLUTION/DROPS;OPHTHALMIC; EQ 0.025% BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALAWAY KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter Yes 021996 BAUSCH AND LOMB
KETOTIFEN FUMARATE KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 077958 AKORN
KETOTIFEN FUMARATE KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 077354 APOTEX INC
KETOTIFEN FUMARATE KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 204059 BAYSHORE PHARMS LLC
ZADITOR KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter No 077200 ALCON PHARMS LTD

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