Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050006
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIBRAMYCIN DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION;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
12/06/1967 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-91 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050006s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050006s091ltr.pdf
07/26/2017 SUPPL-89 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-88 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-87 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-86 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-85 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-84 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-82 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf
02/06/2008 SUPPL-79 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/2008/050006s079ltr.pdf
03/12/2004 SUPPL-76 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50006slr076,50007slr016,50480slr037,50533slr033ltr.pdf
06/18/2002 SUPPL-74 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-73 Efficacy-New Indication

Label is not available on this site.

08/31/1982 SUPPL-72 Labeling

Label is not available on this site.

10/19/1981 SUPPL-71 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1981 SUPPL-70 Manufacturing (CMC)-Control

Label is not available on this site.

09/17/1980 SUPPL-69 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1980 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

08/12/1980 SUPPL-67 Labeling

Label is not available on this site.

09/19/1979 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

09/20/1979 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

10/19/1978 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

07/12/1978 SUPPL-63 Labeling

Label is not available on this site.

07/12/1978 SUPPL-62 Labeling

Label is not available on this site.

03/13/1978 SUPPL-61 Labeling

Label is not available on this site.

09/20/1977 SUPPL-60 Labeling

Label is not available on this site.

09/21/1977 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

09/14/1977 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1976 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1976 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

09/10/1976 SUPPL-55 Manufacturing (CMC)-Control

Label is not available on this site.

05/20/1976 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1976 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/1976 SUPPL-52 Labeling

Label is not available on this site.

12/01/1975 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/1975 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

09/03/1975 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1975 SUPPL-48 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/18/1975 SUPPL-47 Labeling

Label is not available on this site.

09/24/1974 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1974 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

06/21/1974 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/1974 SUPPL-43 Labeling

Label is not available on this site.

04/16/1974 SUPPL-42 Labeling

Label is not available on this site.

10/02/1973 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/1973 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/1973 SUPPL-39 Labeling

Label is not available on this site.

10/30/1973 SUPPL-38 Labeling

Label is not available on this site.

10/30/1973 SUPPL-37 Labeling

Label is not available on this site.

10/30/1973 SUPPL-36 Labeling

Label is not available on this site.

07/02/1973 SUPPL-35 Labeling

Label is not available on this site.

03/16/1973 SUPPL-34 Labeling

Label is not available on this site.

09/18/1972 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

06/23/1972 SUPPL-32 Labeling

Label is not available on this site.

06/09/1972 SUPPL-31 Labeling

Label is not available on this site.

09/16/1971 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

05/25/1971 SUPPL-29 Labeling

Label is not available on this site.

03/12/1971 SUPPL-28 Labeling

Label is not available on this site.

02/22/1971 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1971 SUPPL-26 Labeling

Label is not available on this site.

10/09/1970 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1970 SUPPL-24 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/01/1970 SUPPL-23 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/12/1970 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1970 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

11/19/1969 SUPPL-20 Labeling

Label is not available on this site.

11/07/1969 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1969 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1969 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1969 SUPPL-16 Labeling

Label is not available on this site.

06/12/1969 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1969 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/11/1969 SUPPL-13 Labeling

Label is not available on this site.

12/30/1968 SUPPL-12 Labeling

Label is not available on this site.

12/18/1968 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

06/13/1968 SUPPL-10 Labeling

Label is not available on this site.

06/19/1968 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/08/1968 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/11/1992 SUPPL-7 Labeling

Label is not available on this site.

02/05/1968 SUPPL-6 Manufacturing (CMC)-Expiration Date

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.

11/21/1983 SUPPL-2 Labeling

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-91 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050006s091lbl.pdf
07/26/2017 SUPPL-89 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-88 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s088,050007s031,050442s019,050480s055,050533s044lbl.pdf
03/31/2016 SUPPL-87 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050006s087,050007s030,050442s018,050480s054,050533s043lbledt.pdf
09/12/2014 SUPPL-86 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050006s086,050007s027,050480s052,050533s042lbl.pdf
09/04/2013 SUPPL-85 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s085,05007s026,050480s051,050533s041lbl.pdf
04/29/2013 SUPPL-84 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050006s084,050007s025,050480s050,050533s040lbl.pdf
05/11/2011 SUPPL-82 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050006s082,050007s023,050480s047,050533s038lbl.pdf
02/06/2008 SUPPL-79 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050006s79,050007s20,050480s42,050533s36lbl.pdf

VIBRAMYCIN

FOR SUSPENSION;ORAL; EQ 25MG BASE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXYCYCLINE DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065454 CHARTWELL LIFE SCI
DOXYCYCLINE DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 201678 LUPIN LTD
VIBRAMYCIN DOXYCYCLINE EQ 25MG BASE/5ML FOR SUSPENSION;ORAL Prescription Yes AB 050006 PFIZER

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