Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077841
Company: WEST-WARD PHARMS INT
Company: WEST-WARD PHARMS INT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PENTOSTATIN | PENTOSTATIN | 10MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
08/07/2007 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077841s000ltr.pdf |
PENTOSTATIN
INJECTABLE;INJECTION; 10MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
NIPENT | PENTOSTATIN | 10MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 020122 | HOSPIRA INC |
PENTOSTATIN | PENTOSTATIN | 10MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 077841 | WEST-WARD PHARMS INT |