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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213004
Company: REDHILL

Products on NDA 213004

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213004

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
05/01/2024	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213004s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213004Orig1s014ltr.pdf
07/18/2023	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213004s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213004Orig1s012ltr.pdf
09/08/2023	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213004s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213004Orig1s010ltr.pdf
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

Labels for NDA 213004

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/01/2024	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213004s014lbl.pdf
09/08/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213004s010lbl.pdf
07/18/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213004s012lbl.pdf
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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