Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204836
Company: HETERO LABS LTD V
Company: HETERO LABS LTD V
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | 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 |
---|---|---|---|---|---|---|---|
03/02/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
MOXIFLOXACIN HYDROCHLORIDE
TABLET;ORAL; EQ 400MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 202632 | AUROBINDO PHARMA LTD |
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 207285 | CHARTWELL RX |
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 205348 | CROSSMEDIKA SA |
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 076938 | DR REDDYS |
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 204836 | HETERO LABS LTD V |
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 208682 | MSN |
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET;ORAL | Prescription | No | AB | 077437 | TEVA PHARMS USA |