Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215143
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 100MG/5ML (20MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
08/20/2021 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215143s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215143Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215143Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/01/2022 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215143s003lbl.pdf | |
07/22/2022 | SUPPL-2 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215143Orig1s002ltr.pdf |
03/17/2022 | SUPPL-1 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215143Orig1s001Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215143Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/01/2022 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215143s003lbl.pdf | |
03/17/2022 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215143Orig1s001Lbl.pdf | |
08/20/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215143s000lbl.pdf |
SUCCINYLCHOLINE CHLORIDE
SOLUTION;INTRAMUSCULAR, INTRAVENOUS; 100MG/5ML (20MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 100MG/5ML (20MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 218467 | DR REDDYS |
SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 100MG/5ML (20MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | Yes | AP | 215143 | HIKMA |
SUCCINYLCHOLINE CHLORIDE | SUCCINYLCHOLINE CHLORIDE | 100MG/5ML (20MG/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 217873 | STERISCIENCE |