Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 201678
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION;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
03/18/2013 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/06/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

06/25/2014 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

DOXYCYCLINE

FOR SUSPENSION;ORAL; EQ 25MG BASE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXYCYCLINE DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065454 CHARTWELL LIFE SCI
DOXYCYCLINE DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 201678 LUPIN LTD
VIBRAMYCIN DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION;ORAL Prescription Yes AB 050006 PFIZER

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