Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065146
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 250MG BASE | CAPSULE;ORAL | Prescription | AB | No | No |
CEFACLOR | CEFACLOR | EQ 500MG BASE | CAPSULE;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 |
---|---|---|---|---|---|---|---|
01/22/2004 | 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 |
---|---|---|---|---|---|
09/12/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
09/26/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |
CEFACLOR
CAPSULE;ORAL; EQ 250MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFACLOR | CEFACLOR | EQ 250MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065146 | YUNG SHIN PHARM |
CAPSULE;ORAL; EQ 500MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEFACLOR | CEFACLOR | EQ 500MG BASE | CAPSULE;ORAL | Prescription | No | AB | 065146 | YUNG SHIN PHARM |