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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214752
Company: AMNEAL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATROPINE SULFATE ATROPINE SULFATE 1% SOLUTION/DROPS;OPHTHALMIC Prescription AT No 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
07/14/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214752Orig1s000TA_ltr.pdf

ATROPINE SULFATE

SOLUTION/DROPS;OPHTHALMIC; 1%
TE Code = AT

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 AT 214752 AMNEAL
ATROPINE SULFATE ATROPINE SULFATE 1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 215624 APOTEX
ATROPINE SULFATE ATROPINE SULFATE 1% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 218148 MANKIND PHARMA
ATROPINE SULFATE ATROPINE SULFATE 1% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 206289 RISING
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