Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065447
Company: EPIC PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEMECLOCYCLINE HYDROCHLORIDE DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription AB No No
DEMECLOCYCLINE HYDROCHLORIDE DEMECLOCYCLINE HYDROCHLORIDE 300MG 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
08/18/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/065447Orig1s000ltr.pdf

DEMECLOCYCLINE HYDROCHLORIDE

TABLET;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEMECLOCYCLINE HYDROCHLORIDE DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 065389 AKORN
DEMECLOCYCLINE HYDROCHLORIDE DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 065425 AMNEAL PHARM
DEMECLOCYCLINE HYDROCHLORIDE DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 065171 BARR
DEMECLOCYCLINE HYDROCHLORIDE DEMECLOCYCLINE HYDROCHLORIDE 150MG TABLET;ORAL Prescription No AB 065447 EPIC PHARMA LLC

TABLET;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEMECLOCYCLINE HYDROCHLORIDE DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 065389 AKORN
DEMECLOCYCLINE HYDROCHLORIDE DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 065425 AMNEAL PHARM
DEMECLOCYCLINE HYDROCHLORIDE DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 065171 BARR
DEMECLOCYCLINE HYDROCHLORIDE DEMECLOCYCLINE HYDROCHLORIDE 300MG TABLET;ORAL Prescription No AB 065447 EPIC PHARMA LLC

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