Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215311
Company: STRIDES PHARMA
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBUPROFEN | IBUPROFEN | 100MG/5ML | 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 |
---|---|---|---|---|---|---|---|
05/27/2022 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
IBUPROFEN
SUSPENSION;ORAL; 100MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 074978 | ACTAVIS MID ATLANTIC |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 209178 | AUROBINDO PHARMA LTD |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 076925 | PADAGIS US |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 215311 | STRIDES PHARMA |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 209204 | TARO |