Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 200244
Company: HETERO DRUGS LTD
Company: HETERO DRUGS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMIVUDINE, NEVIRAPINE, AND STAVUDINE | LAMIVUDINE; NEVIRAPINE; STAVUDINE | 150MG; 200MG; 30MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/10/2010 | ORIG-1 | Tentative Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200244s000ltr.pdf |
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