Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204120
Company: HOSPIRA
Company: HOSPIRA
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 | 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 |
---|---|---|---|---|---|---|---|
09/21/2016 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204120Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/27/2019 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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 |