Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203629
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 5MG/10ML (0.5MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 10MG/10ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 3MG/3ML (1MG/ML) | SOLUTION;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 |
---|---|---|---|---|---|---|---|
01/08/2015 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203629s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203629Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203629Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203629Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/04/2021 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203629s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203629Orig1s003ltr.pdf | |
07/31/2015 | SUPPL-1 | 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 |
---|---|---|---|---|---|
02/04/2021 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203629s003lbl.pdf | |
01/08/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203629s000lbl.pdf |
NEOSTIGMINE METHYLSULFATE
SOLUTION;INTRAVENOUS; 3MG/3ML (1MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 3MG/3ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216291 | DR REDDYS |
NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 3MG/3ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 203629 | FRESENIUS KABI USA |
NEOSTIGMINE METHYLSULFATE | NEOSTIGMINE METHYLSULFATE | 3MG/3ML (1MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216206 | HIKMA |