Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208151
Company: ALCON LABS INC
Company: ALCON LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ISOPTO ATROPINE | ATROPINE SULFATE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT2 | 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 |
---|---|---|---|---|---|---|---|
12/01/2016 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208151lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208151Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208151Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/12/2022 | SUPPL-3 | Manufacturing (CMC)-Manufacturing Process |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208151Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208151Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/12/2022 | SUPPL-3 | Manufacturing (CMC)-Manufacturing Process | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208151Orig1s003lbl.pdf | |
12/01/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208151lbl.pdf |
ISOPTO ATROPINE
SOLUTION/DROPS;OPHTHALMIC; 1%
TE Code = AT2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATROPINE SULFATE | ATROPINE SULFATE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT2 | 217791 | SOMERSET |
ISOPTO ATROPINE | ATROPINE SULFATE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT2 | 208151 | ALCON LABS INC |