Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021383
Company: DENTSPLY PHARM
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 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021383s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021383Orig1s011ltr.pdf | |
11/03/2021 | SUPPL-10 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021383Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021383Orig1s010ltr.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 |
---|---|---|---|---|---|
11/03/2021 | SUPPL-10 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021383Orig1s010lbl.pdf | |
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 |