Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203260
Company: HETERO LABS LTD V
Company: HETERO LABS LTD V
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LAMIVUDINE | LAMIVUDINE | 100MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 01/02/2014 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203260Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203260Orig1s000ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/02/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203260Orig1s000lbl.pdf |
LAMIVUDINE
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EPIVIR-HBV | LAMIVUDINE | 100MG | TABLET;ORAL | Prescription | Yes | AB | 021003 | GLAXOSMITHKLINE |
| LAMIVUDINE | LAMIVUDINE | 100MG | TABLET;ORAL | Prescription | No | AB | 211306 | ANNORA |
| LAMIVUDINE | LAMIVUDINE | 100MG | TABLET;ORAL | Prescription | No | AB | 202941 | APOTEX |
| LAMIVUDINE | LAMIVUDINE | 100MG | TABLET;ORAL | Prescription | No | AB | 203260 | HETERO LABS LTD V |
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