Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065055
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE;ORAL Prescription AB No No
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription AB No No
DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE CAPSULE;ORAL Prescription AB No Yes
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;ORAL Discontinued None 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
12/01/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65055ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/23/2016 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

09/26/2014 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

07/10/2014 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065055Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/065055Orig1s013ltr.pdf
12/14/2012 SUPPL-12 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065055s012lbl.pdf
04/18/2012 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

03/12/2009 SUPPL-10 Labeling

Label is not available on this site.

04/15/2005 SUPPL-7 Labeling

Label is not available on this site.

07/15/2005 SUPPL-6

Label is not available on this site.

08/01/2005 SUPPL-5 Labeling

Label is not available on this site.

04/18/2005 SUPPL-4 Labeling

Label is not available on this site.

04/18/2005 SUPPL-3

Label is not available on this site.

02/20/2004 SUPPL-2 Labeling

Label is not available on this site.

12/19/2002 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/10/2014 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065055Orig1s013lbl.pdf
12/14/2012 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065055s012lbl.pdf

DOXYCYCLINE

CAPSULE;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 CAPSULE;ORAL Prescription No AB 204446 ACP NIMBLE
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 204234 LUPIN LTD
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 209396 MAYNE PHARMA INC
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 065055 PAR PHARM
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 065053 SUN PHARM INDS LTD
DOXYCYCLINE DOXYCYCLINE EQ 50MG BASE CAPSULE;ORAL Prescription No AB 205115 ZYDUS PHARMS
MONODOX DOXYCYCLINE EQ 50MG BASE CAPSULE;ORAL Prescription Yes AB 050641 ALMIRALL

CAPSULE;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 CAPSULE;ORAL Prescription No AB 204446 ACP NIMBLE
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 209165 ALEMBIC PHARMS LTD
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 204234 LUPIN LTD
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 209396 MAYNE PHARMA INC
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 065055 PAR PHARM
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 065053 SUN PHARM INDS LTD
DOXYCYCLINE DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 205115 ZYDUS PHARMS
MONODOX DOXYCYCLINE EQ 100MG BASE CAPSULE;ORAL Prescription Yes AB 050641 ALMIRALL

CAPSULE;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 CAPSULE;ORAL Prescription No AB 200065 IMPAX LABS INC
DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 202778 MYLAN PHARMS INC
DOXYCYCLINE DOXYCYCLINE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 065055 PAR PHARM

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