Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065356
Company: SUN PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE TABLET;ORAL Prescription AB No No
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE TABLET;ORAL Prescription AB No No
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE TABLET;ORAL Prescription AB No No
DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE 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
05/31/2006 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
01/16/2015 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/13/2010 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

07/29/2010 SUPPL-3 Labeling

Label is not available on this site.

DOXYCYCLINE

TABLET;ORAL; EQ 50MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE TABLET;ORAL Prescription No AB 091605 HERITAGE PHARMS INC
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE TABLET;ORAL Prescription No AB 065285 LANNETT CO INC
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE TABLET;ORAL Prescription No AB 065070 PAR PHARM
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE TABLET;ORAL Prescription No AB 065356 SUN PHARM INDS LTD
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE TABLET;ORAL Prescription No AB 209582 ZYDUS PHARMS

TABLET;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE TABLET;ORAL Prescription No AB 091605 HERITAGE PHARMS INC
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE TABLET;ORAL Prescription No AB 065285 LANNETT CO INC
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE TABLET;ORAL Prescription No AB 065070 PAR PHARM
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE TABLET;ORAL Prescription No AB 065356 SUN PHARM INDS LTD
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE TABLET;ORAL Prescription No AB 209582 ZYDUS PHARMS

TABLET;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE TABLET;ORAL Prescription No AB 091605 HERITAGE PHARMS INC
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE TABLET;ORAL Prescription No AB 065285 LANNETT CO INC
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE TABLET;ORAL Prescription No AB 065070 PAR PHARM
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE TABLET;ORAL Prescription No AB 065356 SUN PHARM INDS LTD
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE TABLET;ORAL Prescription No AB 209582 ZYDUS PHARMS

TABLET;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE TABLET;ORAL Prescription No AB 091605 HERITAGE PHARMS INC
DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE TABLET;ORAL Prescription No AB 065285 LANNETT CO INC
DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE TABLET;ORAL Prescription No AB 065070 PAR PHARM
DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE TABLET;ORAL Prescription No AB 065356 SUN PHARM INDS LTD
DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE TABLET;ORAL Prescription No AB 209582 ZYDUS PHARMS

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