Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072204
Company: WATSON LABS
Company: WATSON LABS
| 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/15/1988 | 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 |
|---|---|---|---|---|---|
| 02/23/2017 | SUPPL-35 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/03/2010 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 06/04/2009 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 09/08/2008 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 09/03/2008 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 06/17/2002 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/02/2002 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/29/2000 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 01/14/2000 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/29/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/1997 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/31/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/01/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/11/1989 | SUPPL-3 | 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 |