Is Azacitidine still available?

Yes. Azacitidine (NDA 208216) is listed with marketing status Prescription in the FDA Orange Book.

Does Azacitidine have a generic?

Yes. The Orange Book lists 15 approved generic (ANDA) applications sharing Azacitidine's active ingredient (Azacitidine). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What does Azacitidine's TE code AP mean?

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

What is Azacitidine's FDA application number?

Azacitidine is approved under NDA 208216, held by Actavis LLC.

Orange Book product · Brand (NDA)

Azacitidine

Brand (NDA)NDA 208216TE AP Actavis LLC

Approved

Apr 29, 2016

Application

Brand (NDA)

TE code

Listed patents

Azacitidine (Azacitidine) is Actavis LLC's brand-name drug, approved by the FDA under NDA 208216 in 2016. Its therapeutic-equivalence code is AP, so the FDA considers it substitutable for the reference brand. 15 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.
Apr 29, 2016
10 yr 4 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

AZACITIDINE

Strength

100MG/VIAL

Dosage form

POWDER

Route

INTRAVENOUS, SUBCUTANEOUS

TE code

Application

NDA 208216

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Reference standard (RS)

Brand + generics

Active-ingredient family

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

View full Azacitidine 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.

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

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