Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065412
Company: YUNG SHIN PHARM
Company: YUNG SHIN PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFACLOR | CEFACLOR | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | None | No | No |
| CEFACLOR | CEFACLOR | EQ 187MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | None | No | No |
| CEFACLOR | CEFACLOR | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | None | No | No |
| CEFACLOR | CEFACLOR | EQ 375MG BASE/5ML | FOR SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 02/17/2012 | 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 |
|---|---|---|---|---|---|
| 12/23/2024 | SUPPL-7 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/14/2015 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |