Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213663
Company: GRANULES
Company: GRANULES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM | 25MG;220MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/24/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
NAPROXEN SODIUM 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.
TABLET;ORAL; 25MG;220MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ALEVE PM | DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM | 25MG;220MG | TABLET;ORAL | Over-the-counter | Yes | 205352 | BAYER HLTHCARE |
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM | 25MG;220MG | TABLET;ORAL | Over-the-counter | No | 209726 | AMNEAL PHARMS CO |
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM | 25MG;220MG | TABLET;ORAL | Over-the-counter | No | 211830 | COREPHARMA |
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM | 25MG;220MG | TABLET;ORAL | Over-the-counter | No | 213663 | GRANULES |
| NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM | 25MG;220MG | TABLET;ORAL | Over-the-counter | No | 208499 | PERRIGO R AND D |