Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076868
Company: ELITE LABS INC
Company: ELITE LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOXAPINE SUCCINATE | LOXAPINE SUCCINATE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
LOXAPINE SUCCINATE | LOXAPINE SUCCINATE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
LOXAPINE SUCCINATE | LOXAPINE SUCCINATE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
LOXAPINE SUCCINATE | LOXAPINE SUCCINATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
08/04/2005 | 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 |
---|---|---|---|---|---|
02/23/2017 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
04/29/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
11/19/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
09/08/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
LOXAPINE SUCCINATE
CAPSULE;ORAL; EQ 5MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LOXAPINE SUCCINATE | LOXAPINE SUCCINATE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 076868 | ELITE LABS INC |
LOXAPINE SUCCINATE | LOXAPINE SUCCINATE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090695 | LANNETT CO INC |
LOXAPINE SUCCINATE | LOXAPINE SUCCINATE | EQ 5MG BASE | CAPSULE;ORAL | Prescription | No | AB | 072204 | WATSON LABS |
CAPSULE;ORAL; EQ 10MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LOXAPINE SUCCINATE | LOXAPINE SUCCINATE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 076868 | ELITE LABS INC |
LOXAPINE SUCCINATE | LOXAPINE SUCCINATE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090695 | LANNETT CO INC |
LOXAPINE SUCCINATE | LOXAPINE SUCCINATE | EQ 10MG BASE | CAPSULE;ORAL | Prescription | No | AB | 072205 | WATSON LABS |
CAPSULE;ORAL; EQ 25MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LOXAPINE SUCCINATE | LOXAPINE SUCCINATE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 076868 | ELITE LABS INC |
LOXAPINE SUCCINATE | LOXAPINE SUCCINATE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090695 | LANNETT CO INC |
LOXAPINE SUCCINATE | LOXAPINE SUCCINATE | EQ 25MG BASE | CAPSULE;ORAL | Prescription | No | AB | 072206 | WATSON LABS |
CAPSULE;ORAL; EQ 50MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LOXAPINE SUCCINATE | LOXAPINE SUCCINATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 076868 | ELITE LABS INC |
LOXAPINE SUCCINATE | LOXAPINE SUCCINATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 090695 | LANNETT CO INC |
LOXAPINE SUCCINATE | LOXAPINE SUCCINATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | No | AB | 072062 | WATSON LABS |