Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021996
Company: BAUSCH AND LOMB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALAWAY KETOTIFEN FUMARATE EQ 0.025% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter None Yes Yes
ALAWAY KETOTIFEN FUMARATE EQ 0.035% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter None Yes 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
12/01/2006 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021996s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021996_alaway_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/11/2015 SUPPL-8 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021996Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021996Orig1s008ltr.pdf
02/11/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/18/2007 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021996s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021996s001_LTR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/11/2015 SUPPL-8 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021996Orig1s008lbl.pdf
04/18/2007 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021996s001lbl.pdf
04/18/2007 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021996s001lbl.pdf

ALAWAY

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 0.035% BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
ALAWAY KETOTIFEN FUMARATE EQ 0.035% BASE SOLUTION/DROPS;OPHTHALMIC Over-the-counter Yes 021996 BAUSCH AND LOMB

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 077200 ALCON PHARMS LTD

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