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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022556
Company: AYTU

Summary Review

Products on NDA 022556

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KARBINAL ER	CARBINOXAMINE MALEATE	4MG/5ML	SUSPENSION, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022556

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2013	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022556s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022556Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022556Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022556Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/10/2026	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022556Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/022556Orig1s015ltr.pdf
03/25/2021	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022556s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022556Orig1s006ltr.pdf
05/12/2016	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/02/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/10/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022556

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/10/2026	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022556Orig1s015lbl.pdf
03/25/2021	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022556s006lbl.pdf
03/28/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022556s000lbl.pdf

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