Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065070
Company: PAR PHARM
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 100MG BASE TABLET;ORAL Prescription AB No No
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE TABLET;ORAL Prescription AB No No
DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE 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
12/15/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65070ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2017 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

12/20/2015 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

05/31/2013 SUPPL-18 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

12/20/2015 SUPPL-17 Labeling

Label is not available on this site.

03/12/2009 SUPPL-16 Labeling

Label is not available on this site.

07/14/2005 SUPPL-10 Labeling

Label is not available on this site.

07/14/2005 SUPPL-9

Label is not available on this site.

03/26/2004 SUPPL-8 Labeling

Label is not available on this site.

05/21/2003 SUPPL-7 Labeling

Label is not available on this site.

12/30/2002 SUPPL-6 Labeling

Label is not available on this site.

12/30/2002 SUPPL-5 Manufacturing (CMC)-New Strength

Label is not available on this site.

02/26/2002 SUPPL-2 Labeling

Label is not available on this site.

10/17/2001 SUPPL-1 Manufacturing (CMC)-Control

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 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 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 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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