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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203312
Company: IMPAX LABS INC

Summary Review

Products on NDA 203312

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RYTARY	CARBIDOPA; LEVODOPA	23.75MG;95MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
RYTARY	CARBIDOPA; LEVODOPA	36.25MG;145MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
RYTARY	CARBIDOPA; LEVODOPA	48.75MG;195MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
RYTARY	CARBIDOPA; LEVODOPA	61.25MG;245MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203312

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/07/2015	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203312s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203312Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203312Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203312Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2019	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203312s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203312Orig1s011ltr.pdf
10/27/2016	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203312s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203312Orig1s006ltr.pdf
06/03/2016	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/13/2016	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/14/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/14/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203312

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2019	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203312s011lbl.pdf
10/27/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203312s006lbl.pdf
01/07/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203312s000lbl.pdf

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