Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203200
Company: PERRIGO R AND D
Company: PERRIGO R AND D
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE | IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 200MG;10MG | TABLET;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 |
---|---|---|---|---|---|---|---|
07/03/2014 | ORIG-1 | Approval |
Label is not available on this site. |
IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 200MG;10MG
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
ADVIL CONGESTION RELIEF | IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 200MG;10MG | TABLET;ORAL | Over-the-counter | Yes | 022565 | HALEON US HOLDINGS |
IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE | IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE | 200MG;10MG | TABLET;ORAL | Over-the-counter | No | 203200 | PERRIGO R AND D |