Viewing data from:

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.

FOSAMPRENAVIR CALCIUM

ANDA

Tentative Approval

FOSAMPRENAVIR CALCIUM | A204130 | LUPIN LTD

API Supply Chain1 active DMF3 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MATRIX PHARMACORP PRIVATE LTDFOSAMPRENAVIR CALCIUM USP

DMF 255782011

LUPIN LTDInactiveFOSAMPRENAVIR CALCIUM

DMF 255692012

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveFOSAMPRENAVIR CALCIUM

DMF 256492012

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveFOSAMPRENAVIR CALCIUM

DMF 275932014

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

Products (1)

#001 — 700MG

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TABLET;ORAL | TA Date: 2016-07-25 00:00:00

No patent or exclusivity listings for this strength.