Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050480
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIBRAMYCIN DOXYCYCLINE CALCIUM EQ 50MG BASE/5ML SUSPENSION;ORAL Prescription None 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
09/23/1974 ORIG-1 Approval Type 2 - New Active Ingredient STANDARD

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-57 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050480s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050480s057ltr.pdf
07/26/2017 SUPPL-56 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-55 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-54 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
09/12/2014 SUPPL-52 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-51 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-50 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-47 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf
02/06/2008 SUPPL-42 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/2008/050480s042ltr.pdf
03/12/2004 SUPPL-37 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50006slr076,50007slr016,50480slr037,50533slr033ltr.pdf
03/01/2002 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/2002 SUPPL-35 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50006s074ltr.pdf
12/15/1992 SUPPL-34 Efficacy-New Indication

Label is not available on this site.

08/31/1982 SUPPL-33 Labeling

Label is not available on this site.

09/30/1981 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

09/29/1981 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1981 SUPPL-30 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/30/1980 SUPPL-29 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/12/1980 SUPPL-28 Labeling

Label is not available on this site.

10/02/1979 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

01/10/1979 SUPPL-26 Labeling

Label is not available on this site.

11/14/1978 SUPPL-25 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/25/1978 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/1978 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/24/1978 SUPPL-22 Labeling

Label is not available on this site.

07/12/1978 SUPPL-21 Labeling

Label is not available on this site.

03/13/1978 SUPPL-20 Labeling

Label is not available on this site.

11/23/1977 SUPPL-19 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/30/1977 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/23/1977 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1976 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/27/1976 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1976 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/26/1976 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/26/1975 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/21/1975 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/30/1975 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/30/1975 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1975 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1975 SUPPL-7 Labeling

Label is not available on this site.

05/11/1992 SUPPL-6 Labeling

Label is not available on this site.

05/11/1992 SUPPL-5 Labeling

Label is not available on this site.

08/23/1991 SUPPL-4 Labeling

Label is not available on this site.

01/06/1975 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1983 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
12/03/2018 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050480s057lbl.pdf
07/26/2017 SUPPL-56 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-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s088,050007s031,050442s019,050480s055,050533s044lbl.pdf
03/31/2016 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf
09/12/2014 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050006s086,050007s027,050480s052,050533s042lbl.pdf
09/04/2013 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,050480s051,050533s041lbl.pdf
04/29/2013 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,050480s050,050533s040lbl.pdf
05/11/2011 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf
02/06/2008 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480s42,050533s36lbl.pdf

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