Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210027
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE | 500MG/PACKET | POWDER;ORAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
08/20/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210027Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/26/2021 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
09/09/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
09/09/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
SAPROPTERIN DIHYDROCHLORIDE
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 |