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Orange Book product · Brand (NDA)

Azlin

Azlocillin Sodium

Brand (NDA)NDA 050562Discontinued Bayer Pharms
Approved
Sep 03, 1982
Application
Brand (NDA)
TE code
Not listed
Listed patents
0
Azlin (Azlocillin Sodium) is Bayer Pharms's brand-name drug, approved by the FDA under NDA 050562 in 1982. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 2 approved generics share this drug's active ingredient.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.

    Sep 03, 1982

    44 yr 6 mo ago

  2. Today

FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

AZLOCILLIN SODIUM

Strength

EQ 2GM BASE/VIAL

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 050562

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

No

Reference standard (RS)

No

Same application

Other strengths in NDA 050562

Brand + generics

Active-ingredient family

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

View full Azlocillin 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.

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

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