Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205389
Company: MICRO LABS LTD INDIA
Company: MICRO LABS LTD INDIA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EFAVIRENZ | EFAVIRENZ | 50MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
EFAVIRENZ | EFAVIRENZ | 100MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
EFAVIRENZ | EFAVIRENZ | 200MG | TABLET;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 |
---|---|---|---|---|---|---|---|
02/23/2018 | ORIG-1 | Tentative Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Letter (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205389Orig1s000TAltredt.pdf |