Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215624
Company: APOTEX
Company: APOTEX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATROPINE SULFATE | ATROPINE SULFATE | 1% | SOLUTION/DROPS;OPHTHALMIC | Prescription | AT1 | 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 |
---|---|---|---|---|---|---|---|
11/26/2021 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215624Orig1s000ltr.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 |