Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 203259
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 AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/03/2014 | ORIG-1 | Approval |
Label is not available on this site. |
LAMIVUDINE AND ZIDOVUDINE
TABLET;ORAL; 150MG;300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| COMBIVIR | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | Yes | AB | 020857 | VIIV HLTHCARE |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 077558 | AUROBINDO PHARMA LTD |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 202418 | AUROBINDO PHARMA LTD |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 077411 | CIPLA |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 079124 | HETERO LABS LTD III |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 203259 | HETERO LABS LTD V |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 090246 | LUPIN LTD |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 090679 | MACLEODS PHARMS LTD |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 079079 | MYLAN |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 206375 | SHANGHAI DESANO |
| LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 079128 | STRIDES PHARMA |
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