Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203312
Company: IMPAX
Company: IMPAX
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 |
---|---|---|---|---|---|
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. |
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12/14/2015 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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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 |
---|---|---|---|---|---|
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 |