Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090397
Company: BIONPHARMA
Company: BIONPHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;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 |
---|---|---|---|---|---|---|---|
11/22/2010 | ORIG-1 | Approval |
Label is not available on this site. |
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE;ORAL; 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
ADVIL PM | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | Yes | 021393 | HALEON US HOLDINGS |
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 210676 | AUROBINDO PHARMA LTD |
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 090397 | BIONPHARMA |
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN | 25MG;EQ 200MG FREE ACID AND POTASSIUM SALT | CAPSULE;ORAL | Over-the-counter | No | 200888 | STRIDES PHARMA |