Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065058
Company: TEVA
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFACLOR | CEFACLOR | EQ 375MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
CEFACLOR | CEFACLOR | EQ 500MG BASE | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
09/04/2002 | 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 |
---|---|---|---|---|---|
07/27/2021 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
07/24/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
04/27/2010 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
09/22/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |