Is Avinza still available?

Avinza (NDA 021260) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

Does Avinza have a generic?

Yes. The Orange Book lists 37 approved generic (ANDA) applications sharing Avinza's active ingredient (Morphine Sulfate). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Avinza's FDA application number?

Avinza is approved under NDA 021260, held by King Pharms LLC.

Orange Book product · Brand (NDA)

Avinza

Morphine Sulfate

Brand (NDA)NDA 021260Discontinued King Pharms LLC

Approved

Mar 20, 2002

Application

Brand (NDA)

TE code

Not listed

Listed patents

Avinza (Morphine Sulfate) is King Pharms LLC's brand-name drug, approved by the FDA under NDA 021260 in 2002. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 37 approved generics share this drug's active ingredient.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.
Mar 20, 2002
24 yr 8 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

MORPHINE SULFATE

Strength

30MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 021260

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Reference standard (RS)

Same application

Other strengths in NDA 021260

Brand + generics

Active-ingredient family

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

View full Morphine Sulfate 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.

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

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