Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210221
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | AB | No | No |
CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
03/26/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CEPHALEXIN
FOR SUSPENSION;ORAL; EQ 125MG BASE/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 210221 | ALKEM LABS LTD |
CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065234 | LUPIN |
CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 062703 | TEVA |
CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065336 | YUNG SHIN PHARM |
FOR SUSPENSION;ORAL; EQ 250MG BASE/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 210221 | ALKEM LABS LTD |
CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065234 | LUPIN |
CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 062703 | TEVA |
CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065336 | YUNG SHIN PHARM |