Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065053
Company: SUN PHARM INDS LTD
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 Yes
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;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
11/22/2000 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65053ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2014 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

12/14/2012 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

11/30/2011 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

04/14/2009 SUPPL-14 Labeling

Label is not available on this site.

05/20/2005 SUPPL-9 Labeling

Label is not available on this site.

08/17/2004 SUPPL-7 Labeling

Label is not available on this site.

04/30/2003 SUPPL-6 Labeling

Label is not available on this site.

09/10/2003 SUPPL-5 Labeling

Label is not available on this site.

09/10/2003 SUPPL-4 Manufacturing (CMC)-New Strength

Label is not available on this site.

12/23/2002 SUPPL-3 Labeling

Label is not available on this site.

12/13/2001 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/13/2001 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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

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

CAPSULE;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 CAPSULE;ORAL Prescription No AB 204446 ACP NIMBLE
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 209165 ALEMBIC PHARMS LTD
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 204234 LUPIN LTD
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 209396 MAYNE PHARMA INC
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 065053 SUN PHARM INDS LTD
DOXYCYCLINE DOXYCYCLINE EQ 75MG BASE CAPSULE;ORAL Prescription No AB 205115 ZYDUS PHARMS

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