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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213004
Company: REDHILL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TALICIA AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN 250MG;EQ 10MG BASE;12.5MG CAPSULE, DELAYED RELEASE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/01/2019 ORIG-1 Approval Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/213004Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213004Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2022 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213004s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213004Orig1s007ltr.pdf
10/01/2021 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213004s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213004Orig1s004ltr.pdf
11/27/2020 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213004s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213004Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/04/2022 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213004s007lbl.pdf
10/01/2021 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213004s004lbl.pdf
11/27/2020 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213004s002lbl.pdf
11/01/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213004lbl.pdf
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