Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205065
Company: BIOMARIN PHARM
Company: BIOMARIN PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
KUVAN | SAPROPTERIN DIHYDROCHLORIDE | 100MG/PACKET | POWDER;ORAL | Prescription | AB | Yes | Yes |
KUVAN | SAPROPTERIN DIHYDROCHLORIDE | 500MG/PACKET | POWDER;ORAL | Prescription | AB | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/19/2013 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205065s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205065Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205065Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205065Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/26/2024 | SUPPL-8 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022181Orig1s024,205065Orig1s008ltr.pdf |
12/13/2019 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s018,205065s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022181Orig1s018,205065Orig1s007ltr.pdf | |
03/16/2020 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022181s020,205065s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022181Orig1s020, 205065Orig1s006ltr.pdf | |
05/02/2019 | SUPPL-5 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s019,205065s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022181Orig1s019, 205065Orig1s005ltr.pdf | |
08/09/2016 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205065s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205065Orig1s002ltr.pdf | |
10/28/2015 | SUPPL-1 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205065s001lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/16/2020 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022181s020,205065s006lbl.pdf | |
12/13/2019 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s018,205065s007lbl.pdf | |
12/13/2019 | SUPPL-7 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s018,205065s007lbl.pdf | |
05/02/2019 | SUPPL-5 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s019,205065s005lbl.pdf | |
05/02/2019 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022181s019,205065s005lbl.pdf | |
08/09/2016 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205065s002lbl.pdf | |
10/28/2015 | SUPPL-1 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205065s001lbl.pdf |
12/19/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205065s000lbl.pdf |
KUVAN
POWDER;ORAL; 100MG/PACKET
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KUVAN | SAPROPTERIN DIHYDROCHLORIDE | 100MG/PACKET | POWDER;ORAL | Prescription | Yes | AB | 205065 | BIOMARIN PHARM |
SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | 100MG/PACKET | POWDER;ORAL | Prescription | No | AB | 215420 | ANNORA PHARMA |
SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | 100MG/PACKET | POWDER;ORAL | Prescription | No | AB | 209452 | DR REDDYS |
SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | 100MG/PACKET | POWDER;ORAL | Prescription | No | AB | 207207 | ENDO OPERATIONS |
POWDER;ORAL; 500MG/PACKET
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
KUVAN | SAPROPTERIN DIHYDROCHLORIDE | 500MG/PACKET | POWDER;ORAL | Prescription | Yes | AB | 205065 | BIOMARIN PHARM |
SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | 500MG/PACKET | POWDER;ORAL | Prescription | No | AB | 215420 | ANNORA PHARMA |
SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | 500MG/PACKET | POWDER;ORAL | Prescription | No | AB | 215798 | DR REDDYS |
SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | 500MG/PACKET | POWDER;ORAL | Prescription | No | AB | 210027 | ENDO OPERATIONS |