ALAWAY از شرکت BAUSCH AND LOMB

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ALAWAY از شرکت BAUSCH AND LOMB

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
04/14/2021 SUPPL-17 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021996Orig1s017ltr.pdf

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 No 208158 BAUSCH
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 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
بخوانید  ACETAMINOPHEN از شرکت CUSTOPHARM INC
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