Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078785
Company: EMCURE PHARMA
Company: EMCURE PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | 100MG | CAPSULE; ORAL | None (Tentative Approval) | None | No | No |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | 150MG | CAPSULE; ORAL | None (Tentative Approval) | None | No | No |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | 200MG | CAPSULE; ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 02/04/2008 | ORIG-1 | Tentative Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078785s_TAltr.pdf |