Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211890
Company: ALKEM LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBUPROFEN AND FAMOTIDINE FAMOTIDINE; IBUPROFEN 26.6MG;800MG 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
08/03/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211890Orig1s000ltr.pdf

IBUPROFEN AND FAMOTIDINE

TABLET;ORAL; 26.6MG;800MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DUEXIS FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET;ORAL Prescription Yes AB 022519 HORIZON
IBUPROFEN AND FAMOTIDINE FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET;ORAL Prescription No AB 211890 ALKEM LABS LTD
IBUPROFEN AND FAMOTIDINE FAMOTIDINE; IBUPROFEN 26.6MG;800MG TABLET;ORAL Prescription No AB 211278 TEVA PHARMS USA

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