Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 077695
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMIVUDINE | LAMIVUDINE | 10MG/ML | SOLUTION;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 11/21/2016 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/77695TA_ltr.pdf |
LAMIVUDINE
SOLUTION;ORAL; 10MG/ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EPIVIR | LAMIVUDINE | 10MG/ML | SOLUTION;ORAL | Prescription | Yes | AA | 020596 | VIIV HLTHCARE |
| LAMIVUDINE | LAMIVUDINE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 077695 | AUROBINDO PHARMA LTD |
| LAMIVUDINE | LAMIVUDINE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 203564 | SILARX PHARMS INC |
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