Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064166
Company: RANBAXY
Company: RANBAXY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFACLOR | CEFACLOR | EQ 125MG BASE/5ML | FOR SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 10/02/1997 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/064166_cefaclor_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/05/2001 | SUPPL-5 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 02/23/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/30/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/28/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |