Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090168
Company: LEADING
Company: LEADING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 0.5MG | TABLET;ORAL | Prescription | AA | No | No |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG | TABLET;ORAL | Prescription | AA | No | No |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 2MG | TABLET;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
11/28/2012 | ORIG-1 | Approval |
Label is not available on this site. |
BENZTROPINE MESYLATE
TABLET;ORAL; 0.5MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 0.5MG | TABLET;ORAL | Prescription | No | AA | 040103 | AIPING PHARM INC |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 0.5MG | TABLET;ORAL | Prescription | No | AA | 081265 | CHARTWELL RX |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 0.5MG | TABLET;ORAL | Prescription | No | AA | 040715 | ENDO OPERATIONS |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 0.5MG | TABLET;ORAL | Prescription | No | AA | 072264 | EPIC PHARMA LLC |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 0.5MG | TABLET;ORAL | Prescription | No | AA | 090168 | LEADING |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 0.5MG | TABLET;ORAL | Prescription | No | AA | 204713 | NUVO PHARM |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 0.5MG | TABLET;ORAL | Prescription | No | AA | 089058 | PLIVA |
TABLET;ORAL; 1MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG | TABLET;ORAL | Prescription | No | AA | 040103 | AIPING PHARM INC |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG | TABLET;ORAL | Prescription | No | AA | 081265 | CHARTWELL RX |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG | TABLET;ORAL | Prescription | No | AA | 040715 | ENDO OPERATIONS |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG | TABLET;ORAL | Prescription | No | AA | 072265 | EPIC PHARMA LLC |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG | TABLET;ORAL | Prescription | No | AA | 090168 | LEADING |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG | TABLET;ORAL | Prescription | No | AA | 204713 | NUVO PHARM |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG | TABLET;ORAL | Prescription | No | AA | 089059 | PLIVA |
TABLET;ORAL; 2MG
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 2MG | TABLET;ORAL | Prescription | No | AA | 040103 | AIPING PHARM INC |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 2MG | TABLET;ORAL | Prescription | No | AA | 081265 | CHARTWELL RX |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 2MG | TABLET;ORAL | Prescription | No | AA | 040715 | ENDO OPERATIONS |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 2MG | TABLET;ORAL | Prescription | No | AA | 072266 | EPIC PHARMA LLC |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 2MG | TABLET;ORAL | Prescription | No | AA | 090168 | LEADING |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 2MG | TABLET;ORAL | Prescription | No | AA | 204713 | NUVO PHARM |
BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 2MG | TABLET;ORAL | Prescription | No | AA | 089060 | PLIVA |