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General MedicationsORALGeneric

ALEVE-D SINUS & COLD

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

Standard Dose
220MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview ALEVE-D SINUS & COLD is listed in Drugs@FDA under application 021076 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 220MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BAYER Submission history Latest submission status date: 2023-07-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview ALEVE-D SINUS & COLD is listed in Drugs@FDA under application 021076 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 220MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BAYER Submission history Latest submission status date: 2023-07-11 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
ALEVE-D SINUS & COLD (NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE) | Drug Monograph | MedicHelpline