Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 200888
Company: STRIDES PHARMA
Company: STRIDES PHARMA
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 |
---|---|---|---|---|---|---|---|
03/05/2012 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/28/2016 | SUPPL-6 | Labeling-Package Insert |
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 |