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.

LOPINAVIR; RITONAVIR

ANDA

Tentative Approval

LOPINAVIR; RITONAVIR | A090471 | AUROBINDO PHARMA LTD

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 13, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG; 25MG

▴

TABLET; ORAL | TA Date: 2009-03-10 00:00:00

No patent or exclusivity listings for this strength.

#002 — 200MG; 50MG

▾

TABLET; ORAL | TA Date: 2009-03-10 00:00:00