Is Abacavir Sulfate And Lamivudine still available?

Abacavir Sulfate And Lamivudine (NDA 204311) 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 A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.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 Abacavir Sulfate And Lamivudine have a generic?

Yes. The Orange Book lists 9 approved generic (ANDA) applications sharing Abacavir Sulfate And Lamivudine's active ingredient (Abacavir Sulfate; Lamivudine). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Abacavir Sulfate And Lamivudine's FDA application number?

Abacavir Sulfate And Lamivudine is approved under NDA 204311, held by Pharmobedient.

Orange Book product · Brand (NDA)

Abacavir Sulfate And Lamivudine

Abacavir Sulfate; Lamivudine

Brand (NDA)NDA 204311DiscontinuedRLD Pharmobedient

Approved

Dec 22, 2023

Application

Brand (NDA)

TE code

Not listed

Listed patents

Abacavir Sulfate And Lamivudine (Abacavir Sulfate; Lamivudine) is Pharmobedient's brand-name drug, approved by the FDA under NDA 204311 in 2023. 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 Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 9 approved generics share this drug's active ingredient.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.
Dec 22, 2023
2 yr 7 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

ABACAVIR SULFATE; LAMIVUDINE

Strength

EQ 60MG BASE;30MG

Dosage form

TABLET, FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 204311

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

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 Abacavir Sulfate; Lamivudine 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.

Abacavir Sulfate And Lamivudine — 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 Abacavir Sulfate; Lamivudine active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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