Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050007
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIBRAMYCIN DOXYCYCLINE HYCLATE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
VIBRAMYCIN DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription AB Yes 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
12/05/1967 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/03/2018 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050007s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050007s033ltr.pdf
07/26/2017 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045ltr.pdf
12/21/2016 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s088,050007s031,050442s019,050480s055,050533s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s088,050007Orig1s031,050442Orig1s019,050480Orig1s055,050533Orig1s044ltr.pdf
03/31/2016 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050006Orig1s087,050007Orig1s030,050442Orig1s018,050480Orig1s054,050533Orig1s043ltr.pdf
05/05/2015 SUPPL-29 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050007s029lbl.pdf
10/28/2014 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/12/2014 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050006s086,050007s027,050480s052,050533s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050006Orig1s086,050007Orig1s027,050480Orig1s052,050533Orig1s042ltr.pdf
09/04/2013 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,050480s051,050533s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s085,050007Orig1s026,050480Orig1s051,050533Orig1s041ltr.pdf
04/29/2013 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,050480s050,050533s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050006Orig1s084,050007Orig1s025,050480Orig1s050,050533Orig1s040ltr.pdf
05/11/2011 SUPPL-23 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf
02/06/2008 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480s42,050533s36lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050007s020ltr.pdf
03/12/2004 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50006slr076,50007slr016,50480slr037,50533slr033ltr.pdf
05/15/2002 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/18/2002 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf
03/02/2000 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/15/1992 SUPPL-12 Efficacy-New Indication

Label is not available on this site.

05/11/1992 SUPPL-11 Labeling

Label is not available on this site.

05/11/1992 SUPPL-10 Labeling

Label is not available on this site.

07/24/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/23/1991 SUPPL-8 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/03/2018 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050007s033lbl.pdf
07/26/2017 SUPPL-32 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045lbl.pdf
12/21/2016 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s088,050007s031,050442s019,050480s055,050533s044lbl.pdf
03/31/2016 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf
05/05/2015 SUPPL-29 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050007s029lbl.pdf
09/12/2014 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050006s086,050007s027,050480s052,050533s042lbl.pdf
09/04/2013 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,050480s051,050533s041lbl.pdf
04/29/2013 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,050480s050,050533s040lbl.pdf
05/11/2011 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf
02/06/2008 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480s42,050533s36lbl.pdf

VIBRAMYCIN

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 HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 062031 ACTAVIS LABS FL INC
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 210527 ALEMBIC PHARMS LTD
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 207289 AMNEAL PHARMS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 209402 CHANGZHOU PHARM
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 062500 CHARTWELL LIFE SCI
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 062396 HIKMA INTL PHARMS
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 062676 SUN PHARM INDUSTRIES
DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 207774 ZYDUS PHARMS
VIBRAMYCIN DOXYCYCLINE HYCLATE EQ 100MG BASE CAPSULE;ORAL Prescription Yes AB 050007 PFIZER

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