Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214463
Company: PATHEON SOFTGELS
Company: PATHEON SOFTGELS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 200MG BASE | 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 |
---|---|---|---|---|---|---|---|
01/10/2023 | 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 |
---|---|---|---|---|---|
08/09/2023 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
NAPROXEN SODIUM
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CAPSULE;ORAL; EQ 200MG BASE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE;ORAL | Over-the-counter | Yes | 021920 | BIONPHARMA |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE;ORAL | Over-the-counter | No | 202807 | CATALENT |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE;ORAL | Over-the-counter | No | 214463 | PATHEON SOFTGELS |
NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE;ORAL | Over-the-counter | No | 208363 | PURACAP PHARM LLC |