Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210632
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 100MCG/5ML (20MCG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 200MCG/5ML (40MCG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
LEVOTHYROXINE SODIUM | LEVOTHYROXINE SODIUM | 500MCG/5ML (100MCG/ML) | SOLUTION;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
04/11/2019 | 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/2019/210632s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210632Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210632Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210632Orig1s000SumR.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/11/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210632s000lbl.pdf |