Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208820
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PRAZIQUANTEL | PRAZIQUANTEL | 600MG | TABLET;ORAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
11/27/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208820Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/22/2024 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
11/08/2022 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
PRAZIQUANTEL
TABLET;ORAL; 600MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PRAZIQUANTEL | PRAZIQUANTEL | 600MG | TABLET;ORAL | Prescription | No | AB | 208820 | ENDO OPERATIONS |