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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213004
Company: REDHILL

Products on NDA 213004

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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

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

Original Approvals or Tentative Approvals

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Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
11/01/2019	ORIG-1	Approval	Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review

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Supplements

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Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
05/01/2024	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)
09/08/2023	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)
07/18/2023	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)
03/04/2022	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)
10/01/2021	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)
11/27/2020	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)

Showing 1 to 6 of 6 entries

Labels for NDA 213004

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
05/01/2024	SUPPL-14	Labeling-Package Insert	Label (PDF)
09/08/2023	SUPPL-10	Labeling-Package Insert	Label (PDF)
07/18/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)
03/04/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)
10/01/2021	SUPPL-4	Labeling-Package Insert	Label (PDF)
11/27/2020	SUPPL-2	Labeling-Package Insert	Label (PDF)
11/01/2019	ORIG-1	Approval	Label (PDF)

Showing 1 to 7 of 7 entries

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