Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201849
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLUCAGON | GLUCAGON HYDROCHLORIDE | EQ 1MG BASE/VIAL | POWDER;INTRAMUSCULAR, 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 |
|---|---|---|---|---|---|---|---|
| 05/08/2015 | 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/2015/201849Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/201849Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/29/2021 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201849s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201849Orig1s009ltr.pdf | |
| 09/09/2019 | SUPPL-5 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201849s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201849Orig1s005ltr.pdf | |
| 11/03/2015 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/2015 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201849s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201849Orig1s002ltr.pdf | |
| 11/03/2015 | 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 |
|---|---|---|---|---|---|
| 07/29/2021 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201849s009lbl.pdf | |
| 09/09/2019 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201849s005lbl.pdf | |
| 12/01/2015 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201849s002lbl.pdf |
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