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
CIPRODEX از شرکت NOVARTIS
New Drug Application (NDA): 021537
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPRODEX | CIPROFLOXACIN; DEXAMETHASONE | 0.3%;0.1% | SUSPENSION/DROPS;OTIC | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 07/18/2003 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21537ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/03/2020 | SUPPL-18 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021537s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021537Orig1s018ltr.pdf |
||
| 02/21/2019 | SUPPL-17 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021537s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021537Orig1s017ltr.pdf |
||
| 12/10/2015 | SUPPL-12 | Labeling-Patient Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021537s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021537Orig1s012ltr.pdf |
||
| 05/22/2013 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021537Orig1s008.pdf |
|
| 03/01/2004 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/03/2020 | SUPPL-18 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021537s018lbl.pdf | |
| 02/21/2019 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021537s017lbl.pdf | |
| 12/10/2015 | SUPPL-12 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021537s012lbl.pdf |
CIPRODEX
SUSPENSION/DROPS;OTIC; 0.3%;0.1%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIPRODEX | CIPROFLOXACIN; DEXAMETHASONE | 0.3%;0.1% | SUSPENSION/DROPS;OTIC | Prescription | Yes | AB | 021537 | NOVARTIS |
| CIPROFLOXACIN AND DEXAMETHASONE | CIPROFLOXACIN; DEXAMETHASONE | 0.3%;0.1% | SUSPENSION/DROPS;OTIC | Prescription | No | AB | 205548 | DR REDDYS LABS LTD |
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