Assyro AI

Orange Book product · Brand (NDA)

CYANOKIT

HYDROXOCOBALAMIN

Brand (NDA)NDA 022041RX BTG INTL
View HYDROXOCOBALAMIN familyOpen on FDA Orange Book

At a glance

Apr 08, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 08, 2011

    15 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

HYDROXOCOBALAMIN

Strength

5GM/VIAL (5GM/KIT)

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 022041

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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.

Agent CTA Background

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