Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020583
Company: BAUSCH AND LOMB
Company: BAUSCH AND LOMB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOTEMAX | LOTEPREDNOL ETABONATE | 0.5% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
03/09/1998 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20583lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20583ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20583_Lotemax.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/16/2013 | SUPPL-28 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020583Orig1s028.pdf |
10/09/2013 | SUPPL-27 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020583Orig1s027.pdf |
07/11/2006 | SUPPL-13 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
08/30/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/18/2000 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/17/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/19/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/09/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20583lbl.pdf |
LOTEMAX
SUSPENSION/DROPS;OPHTHALMIC; 0.5%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LOTEMAX | LOTEPREDNOL ETABONATE | 0.5% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | Yes | AB | 020583 | BAUSCH AND LOMB |
LOTEPREDNOL ETABONATE | LOTEPREDNOL ETABONATE | 0.5% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 215719 | LUPIN LTD |
LOTEPREDNOL ETABONATE | LOTEPREDNOL ETABONATE | 0.5% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 207609 | SENTISS |
LOTEPREDNOL ETABONATE | LOTEPREDNOL ETABONATE | 0.5% | SUSPENSION/DROPS;OPHTHALMIC | Prescription | No | AB | 212450 | SUN PHARM |