Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | TABLET;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
01/12/1989 | 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 |
---|---|---|---|---|---|
02/22/2011 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
11/16/2009 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
04/18/2012 | SUPPL-22 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063024s022lbl.pdf | |
09/27/2007 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
02/08/2007 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
12/19/2003 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
09/22/2003 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
10/24/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/14/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/20/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/07/2000 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
01/18/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/21/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/28/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/04/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/16/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/06/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/13/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
11/12/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/18/2012 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063024s022lbl.pdf |