Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OFLOXACIN | OFLOXACIN | 200MG | TABLET;ORAL | Prescription | AB | No | No |
OFLOXACIN | OFLOXACIN | 300MG | TABLET;ORAL | Prescription | AB | No | No |
OFLOXACIN | OFLOXACIN | 400MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
09/02/2003 | 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 |
---|---|---|---|---|---|
05/03/2019 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
04/30/2019 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
10/18/2018 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
07/26/2016 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
04/10/2014 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/076182Orig1s014lbl.pdf | |
08/14/2013 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
08/14/2013 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076182Orig1s012ltr.pdf | |
08/13/2013 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified |
Label is not available on this site. |
||
03/10/2011 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
08/13/2013 | SUPPL-9 | REMS-Modified |
Label is not available on this site. |
||
04/21/2010 | SUPPL-8 | REMS-Proposal, Labeling |
Label is not available on this site. |
||
12/19/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
04/25/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
02/06/2008 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
03/16/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
10/17/2006 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
08/30/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
04/08/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/10/2014 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/076182Orig1s014lbl.pdf | |
08/14/2013 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076182Orig1s012ltr.pdf | |
08/14/2013 | SUPPL-12 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076182Orig1s012ltr.pdf |
OFLOXACIN
TABLET;ORAL; 200MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OFLOXACIN | OFLOXACIN | 200MG | TABLET;ORAL | Prescription | No | AB | 091656 | CADILA PHARMS LTD |
OFLOXACIN | OFLOXACIN | 200MG | TABLET;ORAL | Prescription | No | AB | 077098 | DR REDDYS LABS LTD |
OFLOXACIN | OFLOXACIN | 200MG | TABLET;ORAL | Prescription | No | AB | 076182 | TEVA |
TABLET;ORAL; 300MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OFLOXACIN | OFLOXACIN | 300MG | TABLET;ORAL | Prescription | No | AB | 091656 | CADILA PHARMS LTD |
OFLOXACIN | OFLOXACIN | 300MG | TABLET;ORAL | Prescription | No | AB | 077098 | DR REDDYS LABS LTD |
OFLOXACIN | OFLOXACIN | 300MG | TABLET;ORAL | Prescription | No | AB | 076182 | TEVA |
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 |