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 |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021996s000ltr.pdf |
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 |
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 |
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 |
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 |
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