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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213928
Company: CARNEGIE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOCAPROIC ACID AMINOCAPROIC ACID 500MG TABLET;ORAL Prescription AB No No
AMINOCAPROIC ACID AMINOCAPROIC ACID 1GM TABLET;ORAL Prescription AB 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
02/12/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

AMINOCAPROIC ACID

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMICAR AMINOCAPROIC ACID 500MG TABLET;ORAL Prescription Yes AB 015197 AKORN
AMINOCAPROIC ACID AMINOCAPROIC ACID 500MG TABLET;ORAL Prescription No AB 212492 AMNEAL
AMINOCAPROIC ACID AMINOCAPROIC ACID 500MG TABLET;ORAL Prescription No AB 211629 ANI PHARMS
AMINOCAPROIC ACID AMINOCAPROIC ACID 500MG TABLET;ORAL Prescription No AB 213928 CARNEGIE
AMINOCAPROIC ACID AMINOCAPROIC ACID 500MG TABLET;ORAL Prescription No AB 212938 MSN
AMINOCAPROIC ACID AMINOCAPROIC ACID 500MG TABLET;ORAL Prescription No AB 209060 SUNNY

TABLET;ORAL; 1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMICAR AMINOCAPROIC ACID 1GM TABLET;ORAL Prescription Yes AB 015197 AKORN
AMINOCAPROIC ACID AMINOCAPROIC ACID 1GM TABLET;ORAL Prescription No AB 213928 CARNEGIE
AMINOCAPROIC ACID AMINOCAPROIC ACID 1GM TABLET;ORAL Prescription No AB 209060 SUNNY
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