Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040209
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRIFLUOPERAZINE HYDROCHLORIDE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | AB | No | No |
TRIFLUOPERAZINE HYDROCHLORIDE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | AB | No | No |
TRIFLUOPERAZINE HYDROCHLORIDE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | AB | No | No |
TRIFLUOPERAZINE HYDROCHLORIDE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/07/1997 | 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 |
---|---|---|---|---|---|
12/03/2010 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
05/22/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
09/08/2008 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
08/19/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
06/13/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
TRIFLUOPERAZINE HYDROCHLORIDE
TABLET;ORAL; EQ 1MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TRIFLUOPERAZINE HYDROCHLORIDE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 040209 | MYLAN |
TRIFLUOPERAZINE HYDROCHLORIDE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 085785 | SANDOZ |
TABLET;ORAL; EQ 2MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TRIFLUOPERAZINE HYDROCHLORIDE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 040209 | MYLAN |
TRIFLUOPERAZINE HYDROCHLORIDE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 2MG BASE | TABLET;ORAL | Prescription | No | AB | 085786 | SANDOZ |
TABLET;ORAL; EQ 5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TRIFLUOPERAZINE HYDROCHLORIDE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 040209 | MYLAN |
TRIFLUOPERAZINE HYDROCHLORIDE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 5MG BASE | TABLET;ORAL | Prescription | No | AB | 085789 | SANDOZ |
TABLET;ORAL; EQ 10MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TRIFLUOPERAZINE HYDROCHLORIDE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 040209 | MYLAN |
TRIFLUOPERAZINE HYDROCHLORIDE | TRIFLUOPERAZINE HYDROCHLORIDE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 085788 | SANDOZ |