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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210875
Company: SUMITOMO PHARMA AM

Products on NDA 210875

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KYNMOBI	APOMORPHINE HYDROCHLORIDE	10MG	FILM;SUBLINGUAL	Discontinued	None	Yes	No
KYNMOBI	APOMORPHINE HYDROCHLORIDE	15MG	FILM;SUBLINGUAL	Discontinued	None	Yes	No
KYNMOBI	APOMORPHINE HYDROCHLORIDE	20MG	FILM;SUBLINGUAL	Discontinued	None	Yes	No
KYNMOBI	APOMORPHINE HYDROCHLORIDE	25MG	FILM;SUBLINGUAL	Discontinued	None	Yes	No
KYNMOBI	APOMORPHINE HYDROCHLORIDE	30MG	FILM;SUBLINGUAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210875

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/21/2020	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210875lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210875Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/210875Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/05/2022	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210875s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210875Orig1s007ltr.pdf
09/22/2022	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210875s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210875Orig1s006ltr.pdf

Labels for NDA 210875

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/22/2022	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210875s006lbl.pdf
05/05/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210875s007lbl.pdf
05/05/2022	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210875s007lbl.pdf
05/21/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210875lbl.pdf

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