Drugs@FDA: FDA Approved Drug Products

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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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