Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079124
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 AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/17/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/079124s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/19/2023 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
09/19/2024 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
09/19/2024 | SUPPL-10 | Labeling-Package Insert |
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 |
---|---|---|---|---|---|---|---|---|
LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 206375 | ANDA REPOSITORY |
LAMIVUDINE AND ZIDOVUDINE | LAMIVUDINE; ZIDOVUDINE | 150MG;300MG | TABLET;ORAL | Prescription | No | AB | 077558 | AUROBINDO PHARMA |
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 | 079128 | STRIDES PHARMA |