Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 090787
Company: APOTEX INC
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | AB | No | No |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | AB | No | No |
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/29/2011 | 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 |
|---|---|---|---|---|---|
| 05/06/2019 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/24/2019 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/24/2019 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/24/2019 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/24/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/2013 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2013 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
LEVOFLOXACIN
TABLET;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 090787 | APOTEX INC |
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 201043 | AUROBINDO PHARMA LTD |
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 076890 | CIPLA LTD |
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 076710 | DR REDDYS LABS INC |
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 200250 | GLENMARK GENERICS |
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 204968 | HEC PHARM |
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 202801 | HETERO LABS LTD V |
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 203613 | JUBILANT GENERICS |
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 078424 | LUPIN |
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 200839 | MACLEODS PHARMS LTD |
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 202200 | ORCHID HLTHCARE |
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 077438 | SANDOZ |
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 076361 | TEVA |
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 090722 | TORRENT PHARMS |
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 090367 | WOCKHARDT |
| LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 077652 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 090787 | APOTEX INC |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 201043 | AUROBINDO PHARMA LTD |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 076890 | CIPLA LTD |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 076710 | DR REDDYS LABS INC |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 200250 | GLENMARK GENERICS |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 204968 | HEC PHARM |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 202801 | HETERO LABS LTD V |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 203613 | JUBILANT GENERICS |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 078424 | LUPIN |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 200839 | MACLEODS PHARMS LTD |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 202200 | ORCHID HLTHCARE |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 077438 | SANDOZ |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 076361 | TEVA |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 090722 | TORRENT PHARMS |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 090367 | WOCKHARDT |
| LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 077652 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 750MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 090787 | APOTEX INC |
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 201043 | AUROBINDO PHARMA LTD |
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 076890 | CIPLA LTD |
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 076710 | DR REDDYS LABS INC |
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 200250 | GLENMARK GENERICS |
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 204968 | HEC PHARM |
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 202801 | HETERO LABS LTD V |
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 078424 | LUPIN |
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 200839 | MACLEODS PHARMS LTD |
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 202200 | ORCHID HLTHCARE |
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 077438 | SANDOZ |
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 076361 | TEVA |
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 090722 | TORRENT PHARMS |
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 090367 | WOCKHARDT |
| LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 077652 | ZYDUS PHARMS USA INC |
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