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
CITANEST FORTE DENTAL از شرکت DENTSPLY PHARM
New Drug Application (NDA): 021383
Company: DENTSPLY PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CITANEST FORTE DENTAL | EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE | 0.005MG/ML;4% | INJECTABLE;INJECTION | Prescription |
AP |
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 |
|---|---|---|---|---|---|---|---|
| 11/18/1965 | ORIG-1 | Approval |
UNKNOWN |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/02/2018 | SUPPL-11 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021383s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021383Orig1s011ltr.pdf |
||
| 03/03/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/02/2018 | SUPPL-11 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021383s011lbl.pdf |
CITANEST FORTE DENTAL
INJECTABLE;INJECTION; 0.005MG/ML;4%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CITANEST FORTE DENTAL | EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE | 0.005MG/ML;4% | INJECTABLE;INJECTION | Prescription | Yes | AP | 021383 | DENTSPLY PHARM |
| PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE | 0.005MG/ML;4% | INJECTABLE;INJECTION | Prescription | No | AP | 078959 | SEPTODONT INC |
منبع : www.accessdata.fda.gov
نظرات کاربران