Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204968
Company: HEC PHARM
Company: HEC PHARM
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 |
---|---|---|---|---|---|---|---|
02/05/2019 | ORIG-1 | Approval |
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 | CHARTWELL MOLECULAR |
LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 076710 | DR REDDYS LABS INC |
LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 200250 | GLENMARK PHARMS LTD |
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 | 078424 | LUPIN |
LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 200839 | MACLEODS PHARMS LTD |
LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET;ORAL | Prescription | No | AB | 202200 | ORBION PHARMS |
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 | 077652 | ZYDUS LIFESCIENCES |
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 | CHARTWELL MOLECULAR |
LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 076710 | DR REDDYS LABS INC |
LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 200250 | GLENMARK PHARMS LTD |
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 | 078424 | LUPIN |
LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 200839 | MACLEODS PHARMS LTD |
LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET;ORAL | Prescription | No | AB | 202200 | ORBION PHARMS |
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 | 077652 | ZYDUS LIFESCIENCES |
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 | CHARTWELL MOLECULAR |
LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 076710 | DR REDDYS LABS INC |
LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET;ORAL | Prescription | No | AB | 200250 | GLENMARK PHARMS LTD |
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 | ORBION PHARMS |
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 | 077652 | ZYDUS LIFESCIENCES |