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Orange Book product · Brand (NDA)

Bendopa

Levodopa

Brand (NDA)NDA 016948Discontinued Valeant Pharm Intl
Approved
Approved Prior to Jan 1, 1982
Application
Brand (NDA)
TE code
Not listed
Listed patents
0
Bendopa (Levodopa) is Valeant Pharm Intl's brand-name drug, approved by the FDA under NDA 016948. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Key dates

No patent or exclusivity dates are listed for this product.

FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

LEVODOPA

Strength

500MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 016948

Product number

002

Marketing status

Discontinued

Reference listed drug (RLD)

No

Reference standard (RS)

No

Same application

Other strengths in NDA 016948

Brand + generics

Active-ingredient 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.

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

Related FDA reference tools

Agent CTA Background

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