Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091475
Company: HETERO LABS LTD III
Company: HETERO LABS LTD III
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 |
---|---|---|---|---|---|---|---|
10/06/2023 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091475s000ltr.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 |
LAMIVUDINE | LAMIVUDINE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 203564 | CHARTWELL MOLECULAR |
LAMIVUDINE | LAMIVUDINE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 091475 | HETERO LABS LTD III |