Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090198
Company: MACLEODS PHARMS LTD
Company: MACLEODS PHARMS LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | AB | No | No |
LAMIVUDINE | LAMIVUDINE | 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 |
---|---|---|---|---|---|---|---|
05/01/2019 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/090198CR1b_PEPFAR_TALtr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/11/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
LAMIVUDINE
TABLET;ORAL; 150MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EPIVIR | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | Yes | AB | 020564 | VIIV HLTHCARE |
LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 091606 | APOTEX |
LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 077464 | AUROBINDO PHARMA |
LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 203586 | BRECKENRIDGE |
LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 077221 | CIPLA |
LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 203277 | HETERO LABS LTD V |
LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 205217 | LUPIN LTD |
LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 090198 | MACLEODS PHARMS LTD |
LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 090457 | STRIDES PHARMA |
LAMIVUDINE | LAMIVUDINE | 150MG | TABLET;ORAL | Prescription | No | AB | 206974 | UPSHER SMITH LABS |
TABLET;ORAL; 300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EPIVIR | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | Yes | AB | 020564 | VIIV HLTHCARE |
LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 091606 | APOTEX |
LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 077464 | AUROBINDO PHARMA |
LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 077221 | CIPLA |
LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 203277 | HETERO LABS LTD V |
LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 205217 | LUPIN LTD |
LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 090198 | MACLEODS PHARMS LTD |
LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 090457 | STRIDES PHARMA |
LAMIVUDINE | LAMIVUDINE | 300MG | TABLET;ORAL | Prescription | No | AB | 206974 | UPSHER SMITH LABS |