Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208499
Company: PERRIGO R AND D
Company: PERRIGO R AND D
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 |
---|---|---|---|---|---|---|---|
05/10/2019 | 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 |
---|---|---|---|---|---|
10/04/2023 | SUPPL-10 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/04/2023 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
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 |