Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206375
Company: ANDA REPOSITORY
Company: ANDA REPOSITORY
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 |
---|---|---|---|---|---|---|---|
04/10/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/24/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
09/24/2019 | SUPPL-1 | 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 |