Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021996
Company: BAUSCH AND LOMB
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 |
| CHILDREN'S ALAWAY | KETOTIFEN FUMARATE | EQ 0.025% 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 0.025% 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 |
| ALAWAY | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 208158 | BAUSCH AND LOMB INC |
| 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 | 204059 | BAYSHORE PHARMS LLC |
| KETOTIFEN FUMARATE | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 077958 | SENTISS |
| ZADITOR | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 077200 | ALCON PHARMS LTD |
CHILDREN'S 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 0.025% 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 |
| ALAWAY | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 208158 | BAUSCH AND LOMB INC |
| 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 | 204059 | BAYSHORE PHARMS LLC |
| KETOTIFEN FUMARATE | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 077958 | SENTISS |
| ZADITOR | KETOTIFEN FUMARATE | EQ 0.025% BASE | SOLUTION/DROPS;OPHTHALMIC | Over-the-counter | No | 077200 | ALCON PHARMS LTD |