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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

ABACAVIR SULFATE

ANDA

Tentative Approval

ABACAVIR SULFATE | A078742 | MATRIX LABS

API Supply Chain12 active DMFs1 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

MATRIX PHARMACORP PRIVATE LTDABACAVIR SULFATE USP

DMF 182292005

APITORIA PHARMA PRIVATE LTDABACAVIR SULFATE USP

DMF 182562005

OLON SPAABACAVIR SULFATE

DMF 205152007

HETERO LABS LTDABACAVIR SULFATE

DMF 221962008

LUPIN LTDABACAVIR SULFATE USP

DMF 236182010

SIGNA SA DE CVABACAVIR SULFATE USP

DMF 236442010

DR REDDYS LABORATORIES LTDABACAVIR

DMF 244212010

CIPLA LTDABACAVIR SULFATE USP

DMF 262992012

HETERO LABS LTDABACAVIR SULFATE (PROCESS-II), USP

DMF 295872015

LAURUS LABS LTDABACAVIR SULFATE USP (PROCESS-2)

DMF 330312018

CHROMO LABORATORIES INDIA PRIVATE LTDABACAVIR SULFATE USP

DMF 369672024

APITORIA PHARMA PRIVATE LTDABACAVIR SULFATE USP (PROCESS II)

DMF 395372024

LUPIN LTDInactiveABACAVIR SULFATE USP (PROCESS-2)

DMF 348912020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 20, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG

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TABLET; ORAL | TA Date: 2007-04-05 00:00:00

No patent or exclusivity listings for this strength.