Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077200
Company: ALCON PHARMS LTD
Company: ALCON PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZADITOR | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | None | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/02/2008 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/077200Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/16/2015 | SUPPL-2 | Labeling-Package Insert, Labeling-Proprietary Name Change |
Label is not available on this site. |
ZADITOR
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 |
CHILDREN'S 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 | 077354 | APOTEX INC |
KETOTIFEN FUMARATE | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 077958 | SENTISS |
KETOTIFEN FUMARATE | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 204059 | UNICHEM |
ZADITOR | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 077200 | ALCON PHARMS LTD |