Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091677
Company: HETERO LABS LTD III
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPINAVIR AND RITONAVIR LOPINAVIR; RITONAVIR 100MG;25MG TABLET;ORAL Prescription AB No No
LOPINAVIR AND RITONAVIR LOPINAVIR; RITONAVIR 200MG;50MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/04/2021 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/091677Orig1s000ltr.pdf

LOPINAVIR AND RITONAVIR

TABLET;ORAL; 100MG;25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KALETRA LOPINAVIR; RITONAVIR 100MG;25MG TABLET;ORAL Prescription Yes AB 021906 ABBVIE
LOPINAVIR AND RITONAVIR LOPINAVIR; RITONAVIR 100MG;25MG TABLET;ORAL Prescription No AB 091677 HETERO LABS LTD III

TABLET;ORAL; 200MG;50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KALETRA LOPINAVIR; RITONAVIR 200MG;50MG TABLET;ORAL Prescription Yes AB 021906 ABBVIE
LOPINAVIR AND RITONAVIR LOPINAVIR; RITONAVIR 200MG;50MG TABLET;ORAL Prescription No AB 091677 HETERO LABS LTD III

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