Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209060
Company: SUNNY PHARMTECH INC
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 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
11/27/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209060Orig1s000ltr.pdf

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 CLOVER PHARMS
AMINOCAPROIC ACID AMINOCAPROIC ACID 500MG TABLET;ORAL Prescription No AB 209060 SUNNY PHARMTECH INC

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 CLOVER PHARMS
AMINOCAPROIC ACID AMINOCAPROIC ACID 1GM TABLET;ORAL Prescription No AB 209060 SUNNY PHARMTECH INC

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