Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202042
Company: MICRO LABS LTD
Company: MICRO LABS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EFAVIRENZ | EFAVIRENZ | 50MG | CAPSULE; ORAL | None (Tentative Approval) | None | No | No |
EFAVIRENZ | EFAVIRENZ | 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 |
---|---|---|---|---|---|---|---|
01/19/2012 | ORIG-1 | Tentative Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202042s000ltr.pdf |