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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203952
Company: ABBVIE

Products on NDA 203952

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DUOPA	CARBIDOPA; LEVODOPA	4.63MG/ML;20MG/ML	SUSPENSION;ENTERAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203952

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/09/2015	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203952s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203952Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/203952Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/21/2020	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203952s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203952Orig1s011ltr.pdf
12/05/2019	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203952s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203952Orig1s010ltr.pdf
09/15/2016	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203952s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203952Orig1s004ltr.pdf
01/26/2016	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/21/2015	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/22/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203952

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/21/2020	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203952s011lbl.pdf
12/05/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203952s010lbl.pdf
09/15/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203952s004lbl.pdf
01/09/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203952s000lbl.pdf

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