Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089060
Company: PLIVA
Company: PLIVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|
| 08/10/1988 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/10/2001 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/29/2001 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/27/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/13/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/24/1992 | SUPPL-3 | Bioequivalence |
Label is not available on this site. |
||
| 09/24/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
BENZTROPINE MESYLATE
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 | 204713 | ASPEN GLOBAL INC |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 2MG | TABLET;ORAL | Prescription | No | AA | 081265 | CHARTWELL RX |
| 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 | 089060 | PLIVA |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 2MG | TABLET;ORAL | Prescription | No | AA | 040715 | VINTAGE |