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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.

STAVUDINE

ANDA

Tentative Approval

STAVUDINE | A078587 | EMCURE PHARMA

API Supply Chain5 active DMFs9 inactive

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

APITORIA PHARMA PRIVATE LTDSTAVUDINE USP

DMF 179682004

APITORIA PHARMA PRIVATE LTDSTAVUDINE USP (NON-STERILE DRUG SUBSTANCE)

DMF 198372006

ERREDUE SPA INNOVATIVE CHEMICAL AND LIFESTAVUDINE

DMF 198632006

MATRIX PHARMACORP PRIVATE LTDSTAVUDINE USP

DMF 201072007

MATRIX PHARMACORP PRIVATE LTDSTAVUDINE USP (STR)

DMF 204232007

CIPLA LTDInactiveSTAVUDINE USP

DMF 176462004

MYLAN LABORATORIES LTDInactiveSTAVUDINE USP

DMF 179762004

HETERO LABS LTDInactiveSTAVUDINE

DMF 179972005

RANBAXY LABORATORIES LTDInactiveSTAVUDINE USP

DMF 200872006

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDInactiveSTAVUDINE USP

DMF 212792008

SIBRA PHARMACEUTICALS LTD AN ARCH ENTERPRISEInactiveSTAVUDINE USP

DMF 216162008

VITALIFE LABORATORIES (A DIV ARCH PHARMALABS LTD)InactiveSTAVUDINE USP

DMF 219022008

SEQUENT SCIENTIFIC LTDInactiveSTAVUDINE

DMF 230852009

ST PHARM CO LTDInactiveSTAVUDINE DRUG SUBSTANCE

DMF 265292012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 9, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG

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CAPSULE; ORAL | TA Date: 2007-12-12 00:00:00

No patent or exclusivity listings for this strength.