Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065389
Company: AKORN
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
12/01/2008 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/16/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English