Drugs@FDA: FDA-Approved Drugs
Company: LARKEN LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OFLOXACIN | OFLOXACIN | 200MG | TABLET;ORAL | Discontinued | None | No | No |
OFLOXACIN | OFLOXACIN | 300MG | TABLET;ORAL | Discontinued | None | No | No |
OFLOXACIN | OFLOXACIN | 400MG | 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 |
---|---|---|---|---|---|---|---|
09/02/2003 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/76093.ta.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/22/2019 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
10/18/2018 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
07/26/2016 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
10/26/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
03/20/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
12/22/2014 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
03/05/2015 | SUPPL-5 | Labeling-Container/Carton Labels, REMS-Modified, Labeling-Package Insert |
Label is not available on this site. |
||
11/04/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
04/22/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
04/05/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |
OFLOXACIN
TABLET;ORAL; 400MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OFLOXACIN | OFLOXACIN | 400MG | TABLET;ORAL | Prescription | No | AB | 091656 | CADILA PHARMS LTD |
OFLOXACIN | OFLOXACIN | 400MG | TABLET;ORAL | Prescription | No | AB | 077098 | DR REDDYS LABS LTD |
OFLOXACIN | OFLOXACIN | 400MG | TABLET;ORAL | Prescription | No | AB | 076093 | LARKEN LABS |
OFLOXACIN | OFLOXACIN | 400MG | TABLET;ORAL | Prescription | No | AB | 076182 | TEVA |