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Orange Book product · Brand (NDA)

Alomide

Lodoxamide Tromethamine

Brand (NDA)NDA 020191DiscontinuedRLD Novartis
Approved
Sep 23, 1993
Application
Brand (NDA)
TE code
Not listed
Listed patents
0
Alomide (Lodoxamide Tromethamine) is Novartis's brand-name drug, approved by the FDA under NDA 020191 in 1993. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness.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

  1. Approval

    FDA approval date of this drug product.

    Sep 23, 1993

    33 yr 3 mo ago

  2. Today

FDA product record

Pharmaceutical detail

Pharmaceutical detail

Active ingredient

LODOXAMIDE TROMETHAMINE

Strength

EQ 0.1% BASE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 020191

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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.

No other applications share this active ingredient.

View full Lodoxamide Tromethamine 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.

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

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