Drugs@FDA: FDA-Approved Drugs
Company: TEVA BRANDED PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOXITANE | LOXAPINE SUCCINATE | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| LOXITANE | LOXAPINE SUCCINATE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| LOXITANE | LOXAPINE SUCCINATE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| LOXITANE | LOXAPINE SUCCINATE | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| LOXITANE | LOXAPINE SUCCINATE | EQ 10MG BASE **Federal Register determination that product was discontinued or withdrawn for s or e reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| LOXITANE | LOXAPINE SUCCINATE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| LOXITANE | LOXAPINE SUCCINATE | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 02/25/1975 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
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-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017525s051,017658s038,018039s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017658Orig1s038,018039Orig1s024,017525Orig1s051ltr.pdf | |
| 09/16/1998 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 01/28/1997 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/25/1996 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/1995 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/16/1991 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1994 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/1994 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1990 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/1989 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1989 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1987 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/02/1986 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/1985 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1983 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1982 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/1983 | SUPPL-22 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/10/1983 | SUPPL-21 | Efficacy |
Label is not available on this site. |
||
| 10/08/1981 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 10/08/1981 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 01/06/1981 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/1979 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1980 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1979 | SUPPL-14 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/08/1978 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/25/1978 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 06/08/1978 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/23/1976 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/25/1977 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/30/1976 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/04/1976 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/04/1976 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/04/1976 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1977 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/23/2017 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017525s051,017658s038,018039s024lbl.pdf |