Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076589
Company: DR REDDYS
Company: DR REDDYS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUMAZENIL | FLUMAZENIL | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
FLUMAZENIL | FLUMAZENIL | 0.5MG/5ML (0.1MG/ML) | INJECTABLE;INJECTION | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
10/12/2004 | ORIG-1 | Approval |
Label is not available on this site. |