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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214652
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATROPINE SULFATE ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION;INTRAVENOUS Prescription AP Yes Yes
ATROPINE SULFATE ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription AP 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
09/29/2020 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214652s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/214652Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/214652Orig1s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/29/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214652s000lbl.pdf

ATROPINE SULFATE

SOLUTION;INTRAVENOUS; 0.4MG/ML (0.4MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATROPINE SULFATE ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 214652 ACCORD HLTHCARE
ATROPINE SULFATE ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216120 AM REGENT
ATROPINE SULFATE ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 215969 SOMERSET THERAPS LLC

SOLUTION;INTRAVENOUS; 1MG/ML (1MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATROPINE SULFATE ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 214652 ACCORD HLTHCARE
ATROPINE SULFATE ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 216120 AM REGENT
ATROPINE SULFATE ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 215969 SOMERSET THERAPS LLC
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