Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210149
Company: GUARDIAN DRUG
Company: GUARDIAN DRUG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | 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 |
---|---|---|---|---|---|---|---|
08/17/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/10/2022 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
05/15/2019 | SUPPL-1 | Labeling |
Label is not available on this site. |
IBUPROFEN
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUSPENSION;ORAL; 100MG/5ML
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CHILDREN'S ADVIL | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 020589 | HALEON US HOLDINGS |
CHILDREN'S ADVIL-FLAVORED | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 020589 | HALEON US HOLDINGS |
CHILDREN'S IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 074937 | PERRIGO |
CHILDREN'S MOTRIN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | Yes | 020516 | J AND J CONSUMER INC |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 210602 | APTAPHARMA INC |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 209179 | AUROBINDO PHARMA LTD |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 210149 | GUARDIAN DRUG |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 074916 | P AND L |
IBUPROFEN | IBUPROFEN | 100MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 209207 | TARO |