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
BSS از شرکت ALCON
New Drug Application (NDA): 020742
Company: ALCON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BSS | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION;IRRIGATION | Prescription |
AT |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 12/10/1997 | ORIG-1 | Approval |
Type 4 – New Combination |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/06/2015 | SUPPL-26 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020742s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020742Orig1s025,026ltr.pdf |
||
| 11/06/2015 | SUPPL-25 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020742s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020742Orig1s025,026ltr.pdf |
||
| 11/15/2012 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/2009 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020742s020ltr.pdf |
|
| 09/30/2004 | SUPPL-8 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20742s008ltr.pdf |
||
| 05/25/2004 | SUPPL-6 | Manufacturing (CMC)-Packaging |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742slr005,scp006_bss_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20742slr005,scp006ltr.pdf |
||
| 05/25/2004 | SUPPL-5 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742slr005,scp006_bss_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20742slr005,scp006ltr.pdf |
||
| 04/15/2003 | SUPPL-4 | Manufacturing (CMC)-Packaging |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020742s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20742scp004ltr.pdf |
||
| 07/09/2003 | SUPPL-3 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20742slr003_aqualase_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20742slr003ltr.pdf |
||
| 10/30/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/06/2015 | SUPPL-26 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020742s025s026lbl.pdf |
| 11/06/2015 | SUPPL-25 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020742s025s026lbl.pdf | |
| 09/30/2004 | SUPPL-8 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742s008lbl.pdf | |
| 05/25/2004 | SUPPL-6 |
Manufacturing (CMC)-Packaging |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742slr005,scp006_bss_lbl.pdf | |
| 05/25/2004 | SUPPL-5 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20742slr005,scp006_bss_lbl.pdf | |
| 07/09/2003 | SUPPL-3 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20742slr003_aqualase_lbl.pdf | |
| 04/15/2003 | SUPPL-4 |
Manufacturing (CMC)-Packaging |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020742s004lbl.pdf |
BSS
SOLUTION;IRRIGATION; 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BALANCED SALT | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION;IRRIGATION | Prescription | No | AT | 075503 | AKORN |
| BALANCED SALT | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION;IRRIGATION | Prescription | No | AT | 091387 | B BRAUN |
| BSS | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | SOLUTION;IRRIGATION | Prescription | Yes | AT | 020742 | ALCON |
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