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Abbreviated New Drug Application (ANDA): 212868
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATROPINE SULFATE ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
ATROPINE SULFATE ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
ATROPINE SULFATE ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION;INTRAVENOUS Prescription AP 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
07/26/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212868Orig1s000ltr.pdf

ATROPINE SULFATE

SOLUTION;INTRAVENOUS; 0.25MG/5ML (0.05MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATROPINE SULFATE ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 212868 ACCORD HLTHCARE
ATROPINE SULFATE ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 021146 HOSPIRA

SOLUTION;INTRAVENOUS; 0.5MG/5ML (0.1MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATROPINE SULFATE ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 212868 ACCORD HLTHCARE
ATROPINE SULFATE ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 215342 AMNEAL
ATROPINE SULFATE ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 021146 HOSPIRA

SOLUTION;INTRAVENOUS; 1MG/10ML (0.1MG/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/10ML (0.1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 212868 ACCORD HLTHCARE
ATROPINE SULFATE ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 021146 HOSPIRA
ATROPINE SULFATE ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 212461 INTL MEDICATION SYS
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