Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214235
Company: CAPLIN
Company: CAPLIN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ARGATROBAN | ARGATROBAN | 50MG/50ML (1MG/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 |
---|---|---|---|---|---|---|---|
01/21/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214235Orig1s000ltr.pdf |
ARGATROBAN
INJECTABLE;INJECTION; 50MG/50ML (1MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ARGATROBAN | ARGATROBAN | 50MG/50ML (1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 214235 | CAPLIN |
ARGATROBAN | ARGATROBAN | 50MG/50ML (1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 217848 | GLAND PHARMA LTD |
ARGATROBAN | ARGATROBAN | 50MG/50ML (1MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 203049 | HIKMA PHARM CO LTD |