Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091525
Company: NAVINTA LLC
Company: NAVINTA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 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 |
---|---|---|---|---|---|---|---|
02/05/2013 | ORIG-1 | Approval |
Label is not available on this site. |
BENZTROPINE MESYLATE
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090233 | FRESENIUS KABI USA |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209442 | HIKMA |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090287 | HIKMA FARMACEUTICA |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091525 | NAVINTA LLC |