Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 212780
Company: AMNEAL PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOCAPROIC ACID AMINOCAPROIC ACID 1.25GM/5ML SYRUP;ORAL Prescription AA 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
08/23/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212780Orig1s000ltr.pdf

AMINOCAPROIC ACID

SYRUP;ORAL; 1.25GM/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMICAR AMINOCAPROIC ACID 1.25GM/5ML SYRUP;ORAL Prescription Yes AA 015230 CLOVER PHARMS
AMINOCAPROIC ACID AMINOCAPROIC ACID 1.25GM/5ML SYRUP;ORAL Prescription No AA 212780 AMNEAL PHARMS LLC

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