Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050442
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIBRAMYCIN DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
VIBRAMYCIN DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
09/05/1972 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
07/26/2017 SUPPL-20 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/2017/050442s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050006Orig1s089,050007Orig1s032,050442Orig1s020,050480Orig1s056,050533Orig1s045ltr.pdf
12/21/2016 SUPPL-19 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-18 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
09/24/2014 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050442s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050442Orig1s017ltr.pdf
09/11/2013 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050442s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050442Orig1s016ltr.pdf
06/18/2002 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf
05/11/1981 SUPPL-14 Labeling

Label is not available on this site.

03/07/1978 SUPPL-12 Labeling

Label is not available on this site.

10/03/1977 SUPPL-11 Labeling

Label is not available on this site.

09/21/1977 SUPPL-10 Efficacy-New Dosing Regimen

Label is not available on this site.

09/03/1976 SUPPL-9 Efficacy-New Dosing Regimen

Label is not available on this site.

12/11/1972 SUPPL-7 Efficacy-New Dosing Regimen

Label is not available on this site.

05/11/1992 SUPPL-6 Labeling

Label is not available on this site.

08/03/1989 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/26/2017 SUPPL-20 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/2017/050442s020lbl.pdf
12/21/2016 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s088,050007s031,050442s019,050480s055,050533s044lbl.pdf
03/31/2016 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf
09/24/2014 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050442s017lbl.pdf
09/11/2013 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050442s016lbl.pdf

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