Is Ak-fluor 10% still available?

Yes. Ak-fluor 10% (NDA 022186) is listed with marketing status Prescription in the FDA Orange Book.

Does Ak-fluor 10% have a generic?

Yes. The Orange Book lists 3 approved generic (ANDA) applications sharing Ak-fluor 10%'s active ingredient (Fluorescein Sodium). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What does Ak-fluor 10%'s TE code AP mean?

AP is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Ak-fluor 10% substitutable for its reference brand with no expected difference in clinical effect.

What is Ak-fluor 10%'s FDA application number?

Ak-fluor 10% is approved under NDA 022186, held by Long Grove Pharms.

Orange Book product · Brand (NDA)

Ak-fluor 10%

Fluorescein Sodium

Brand (NDA)NDA 022186TE APRLD Long Grove Pharms

Approved

Aug 08, 2008

Application

Brand (NDA)

TE code

Listed patents

Ak-fluor 10% (Fluorescein Sodium) is Long Grove Pharms's brand-name drug, approved by the FDA under NDA 022186 in 2008. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its therapeutic-equivalence code is AP, so the FDA considers it substitutable for the reference brand. 3 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 08, 2008
18 yr 2 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

FLUORESCEIN SODIUM

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Application

NDA 022186

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Same application

Other strengths in NDA 022186

EQ 500MG BASE/2ML (EQ 250MG BASE/ML)INJECTABLE

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 Fluorescein Sodium 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.

Ak-fluor 10% — 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 Fluorescein Sodium active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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