Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201006
Company: BAUSCH AND LOMB
Company: BAUSCH AND LOMB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LATANOPROST | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
03/22/2011 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/27/2023 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
09/03/2021 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
02/21/2020 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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12/09/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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02/27/2013 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
LATANOPROST
SOLUTION/DROPS;OPHTHALMIC; 0.005%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LATANOPROST | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 200925 | AMRING PHARMS |
LATANOPROST | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 201006 | BAUSCH AND LOMB |
LATANOPROST | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 202077 | CARNEGIE |
LATANOPROST | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 202442 | FDC LTD |
LATANOPROST | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 091449 | SANDOZ |
LATANOPROST | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 201786 | SOMERSET |
XALATAN | LATANOPROST | 0.005% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 020597 | UPJOHN |