Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204079
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT2 | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/28/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204079Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2021 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
12/31/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
MOXIFLOXACIN HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT2 | 204079 | LUPIN LTD |