Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202807
Company: CATALENT
Company: CATALENT
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 |
---|---|---|---|---|---|---|---|
01/04/2019 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/19/2023 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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09/19/2023 | SUPPL-7 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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04/09/2020 | SUPPL-3 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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04/09/2020 | SUPPL-2 | 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 |