Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204051
Company: SUN PHARMA GLOBAL
Company: SUN PHARMA GLOBAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZOLEDRONIC ACID | ZOLEDRONIC ACID | 4MG/100ML | INJECTABLE;INJECTION | None (Tentative Approval) | None | 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 |
---|---|---|---|---|---|---|---|
07/03/2014 | ORIG-1 | Tentative Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204051Orig1s000TAltr.pdf |