Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206888
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TIROFIBAN HYDROCHLORIDE | TIROFIBAN HYDROCHLORIDE | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
04/08/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206888Orig1s000ltr.pdf |
TIROFIBAN HYDROCHLORIDE
SOLUTION;INTRAVENOUS; EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AGGRASTAT | TIROFIBAN HYDROCHLORIDE | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 020913 | MEDICURE |
TIROFIBAN HYDROCHLORIDE | TIROFIBAN HYDROCHLORIDE | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 216379 | EUGIA PHARMA |
TIROFIBAN HYDROCHLORIDE | TIROFIBAN HYDROCHLORIDE | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 206888 | GLAND PHARMA LTD |
TIROFIBAN HYDROCHLORIDE | TIROFIBAN HYDROCHLORIDE | EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 213947 | NEXUS |