Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201811
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ARGATROBAN | ARGATROBAN | 250MG/2.5ML (100MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/23/2015 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201811s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201811Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/201811Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/201811Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/30/2018 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201811s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201811Orig1s006ltr.pdf | |
05/25/2016 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201811s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201811Orig1s003ltr.pdf | |
12/11/2015 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/30/2018 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201811s006lbl.pdf | |
05/25/2016 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201811s003lbl.pdf | |
03/23/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201811s000lbl.pdf |
ARGATROBAN
INJECTABLE;INJECTION; 250MG/2.5ML (100MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARGATROBAN | ARGATROBAN | 250MG/2.5ML (100MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 206698 | AMNEAL PHARMS CO |
ARGATROBAN | ARGATROBAN | 250MG/2.5ML (100MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091665 | ENDO OPERATIONS |
ARGATROBAN | ARGATROBAN | 250MG/2.5ML (100MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 201811 | FRESENIUS KABI USA |
ARGATROBAN | ARGATROBAN | 250MG/2.5ML (100MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 203049 | HIKMA PHARM CO LTD |
ARGATROBAN | ARGATROBAN | 250MG/2.5ML (100MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 204120 | HOSPIRA |
ARGATROBAN | ARGATROBAN | 250MG/2.5ML (100MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 202626 | MYLAN INSTITUTIONAL |