Is Banan still available?

Banan (NDA 050688) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

Does Banan have a generic?

Yes. The Orange Book lists 8 approved generic (ANDA) applications sharing Banan's active ingredient (Cefpodoxime Proxetil). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Banan's FDA application number?

Banan is approved under NDA 050688, held by Sankyo.

Orange Book product · Brand (NDA)

Banan

Cefpodoxime Proxetil

Brand (NDA)NDA 050688Discontinued Sankyo

Approved

Aug 07, 1992

Application

Brand (NDA)

TE code

Not listed

Listed patents

Banan (Cefpodoxime Proxetil) is Sankyo's brand-name drug, approved by the FDA under NDA 050688 in 1992. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 8 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Aug 07, 1992
34 yr 5 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

CEFPODOXIME PROXETIL

Strength

EQ 50MG BASE/5ML

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 050688

Product number

002

Marketing status

Discontinued

Reference listed drug (RLD)

Reference standard (RS)

Same application

Other strengths in NDA 050688

EQ 100MG BASE/5MLFOR SUSPENSION

Brand + generics

Active-ingredient family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

View full Cefpodoxime Proxetil family

Orange Book patent file

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.

Banan — 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 Cefpodoxime Proxetil active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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