Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 206289
Company: RISING
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATROPINE SULFATE | ATROPINE SULFATE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT1 | Yes | 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 |
---|---|---|---|---|---|---|---|
07/18/2014 | ORIG-1 | Approval | Type 7 - Drug Already Marketed without Approved NDA | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206289s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206289Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206289Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206289Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/18/2022 | SUPPL-11 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206289Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206289Orig1s011ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/18/2022 | SUPPL-11 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206289Orig1s011lbl.pdf | |
07/18/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206289s000lbl.pdf |
ATROPINE SULFATE
SOLUTION/DROPS;OPHTHALMIC; 1%
TE Code = AT1
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 | AT1 | 214752 | AMNEAL |
ATROPINE SULFATE | ATROPINE SULFATE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 215624 | APOTEX |
ATROPINE SULFATE | ATROPINE SULFATE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT1 | 218148 | MANKIND PHARMA |
ATROPINE SULFATE | ATROPINE SULFATE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT1 | 206289 | RISING |