Drugs@FDA: FDA-Approved Drugs
Company: TEVA BRANDED PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOXITANE C | LOXAPINE HYDROCHLORIDE | EQ 25MG BASE/ML | CONCENTRATE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 05/04/1976 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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-38 | 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 | |
| 09/26/2000 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/10/2000 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1998 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 01/28/1998 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1997 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1994 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1994 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/29/1994 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1990 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/03/1987 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1984 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/10/1983 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/17/1983 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1982 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/26/1981 | SUPPL-15 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 04/03/1981 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/14/1981 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/08/1981 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/06/1981 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1979 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/16/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/11/1977 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/03/1977 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/21/1977 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/21/1977 | SUPPL-3 | Manufacturing (CMC)-Formulation |
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-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017525s051,017658s038,018039s024lbl.pdf |