Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022485
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ARGATROBAN IN SODIUM CHLORIDE | ARGATROBAN | 125MG/125ML (1MG/ML) | INJECTABLE;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 |
---|---|---|---|---|---|---|---|
05/09/2011 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022485lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022485s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022485s000(1)ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022485_argatroban_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022485Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/29/2019 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022485s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022485Orig1s013ltr.pdf | |
07/03/2018 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022485s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022485Orig1s011ltr.pdf | |
05/26/2016 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022485s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022485Orig1s009ltr.pdf | |
12/01/2015 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/11/2014 | SUPPL-2 | 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 |
---|---|---|---|---|---|
04/29/2019 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022485s013lbl.pdf | |
07/03/2018 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022485s011lbl.pdf | |
05/26/2016 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022485s009lbl.pdf | |
05/09/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022485lbl.pdf |
ARGATROBAN IN SODIUM CHLORIDE
INJECTABLE;INTRAVENOUS; 125MG/125ML (1MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARGATROBAN IN SODIUM CHLORIDE | ARGATROBAN | 125MG/125ML (1MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205570 | GLAND PHARMA LTD |
ARGATROBAN IN SODIUM CHLORIDE | ARGATROBAN | 125MG/125ML (1MG/ML) | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 022485 | SANDOZ |