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FDA Orange Book · active-ingredient family

Abacavir sulfate; lamivudine; zidovudine

Abacavir sulfate; lamivudine; zidovudine is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TRIZIVIR · NDA 021205

1

Brand (NDA)

1

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
TRIZIVIRRLDVIIV HLTHCARENDA 021205Nov 14, 2000

Generic (ANDA) products (1)

ProductApplicantApplicationTEApproved
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINELUPINANDA 202912Dec 05, 2013

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; lamivudine; zidovudine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.