Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090083
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | AB | No | No |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 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 |
|---|---|---|---|---|---|---|---|
| 10/06/2010 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/01/2022 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/21/2020 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/10/2016 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/07/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2014 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/11/2013 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/20/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/20/2012 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/20/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/22/2010 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
LOSARTAN POTASSIUM
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| COZAAR | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | Yes | AB | 020386 | ORGANON |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 090428 | ALEMBIC PHARMS LTD |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 090083 | AUROBINDO PHARMA |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 077424 | CHARTWELL RX |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 215959 | GRANULES |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 203835 | HETERO LABS LTD V |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 200290 | IPCA LABS LTD |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 201170 | JUBILANT CADISTA |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 078232 | LUPIN LTD |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 202230 | MACLEODS PHARMS LTD |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 091541 | MICRO LABS |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 217396 | MSN |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 091497 | PRINSTON INC |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 090382 | STRIDES PHARMA |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 203030 | UNICHEM |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 091129 | WATSON LABS |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 25MG | TABLET;ORAL | Prescription | No | AB | 078243 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| COZAAR | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | Yes | AB | 020386 | ORGANON |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 090428 | ALEMBIC PHARMS LTD |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 090083 | AUROBINDO PHARMA |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 077424 | CHARTWELL RX |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 215959 | GRANULES |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 203835 | HETERO LABS LTD V |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 200290 | IPCA LABS LTD |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 201170 | JUBILANT CADISTA |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 078232 | LUPIN LTD |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 202230 | MACLEODS PHARMS LTD |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 091541 | MICRO LABS |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 217396 | MSN |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 091497 | PRINSTON INC |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 090382 | STRIDES PHARMA |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 203030 | UNICHEM |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 091129 | WATSON LABS |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 50MG | TABLET;ORAL | Prescription | No | AB | 078243 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| COZAAR | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | Yes | AB | 020386 | ORGANON |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 090428 | ALEMBIC PHARMS LTD |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 090083 | AUROBINDO PHARMA |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 077424 | CHARTWELL RX |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 215959 | GRANULES |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 203835 | HETERO LABS LTD V |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 200290 | IPCA LABS LTD |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 201170 | JUBILANT CADISTA |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 078232 | LUPIN LTD |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 202230 | MACLEODS PHARMS LTD |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 091541 | MICRO LABS |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 217396 | MSN |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 091497 | PRINSTON INC |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 090382 | STRIDES PHARMA |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 203030 | UNICHEM |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 091129 | WATSON LABS |
| LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | 100MG | TABLET;ORAL | Prescription | No | AB | 078243 | ZYDUS PHARMS USA INC |