Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062774
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 1GM BASE | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 04/08/1987 | 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 |
|---|---|---|---|---|---|
| 04/18/2012 | SUPPL-16 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062774s016lbl.pdf | |
| 06/30/2008 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/20/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/23/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 08/23/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/23/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/23/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/21/1992 | SUPPL-1 | Manufacturing (CMC) |
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-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/062774s016lbl.pdf |
CEFADROXIL
TABLET;ORAL; EQ 1GM BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 1GM BASE | TABLET;ORAL | Prescription | No | AB | 062774 | TEVA PHARMS |