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Orange Book product · Brand (NDA)

Aleve Pm

Diphenhydramine Hydrochloride; Naproxen Sodium

Brand (NDA)NDA 205352RLD Bayer Hlthcare
Approved
Jan 17, 2014
Application
Brand (NDA)
TE code
Not listed
Listed patents
0
Aleve Pm (Diphenhydramine Hydrochloride; Naproxen Sodium) is Bayer Hlthcare's brand-name drug, approved by the FDA under NDA 205352 in 2014. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. 5 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 17, 2014

    12 yr 8 mo ago

  2. Today

FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

Strength

25MG;220MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 205352

Product number

001

Marketing status

Over-the-counter

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Diphenhydramine Hydrochloride; Naproxen Sodium family
Orange Book patent file

Listed patents

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Aleve Pm — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Diphenhydramine Hydrochloride; Naproxen Sodium active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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