Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202832
Company: MEDEFIL INC
Company: MEDEFIL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 9MG/ML (9MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 18MG/2ML (9MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 22.5MG/2.5ML (9MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 27MG/3ML (9MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 45MG/5ML (9MG/ML) | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | INJECTABLE;INJECTION | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
01/06/2012 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202832s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202832_sodiumc_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/26/2022 | SUPPL-6 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202832Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202832Orig1s006ltr.pdf | |
11/29/2017 | SUPPL-2 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202832Orig1s002ltr.pdf |
09/27/2012 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202832s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202832Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
10/26/2022 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202832Orig1s006lbl.pdf | |
09/27/2012 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202832s001lbl.pdf | |
09/27/2012 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202832s001lbl.pdf |