FDA.reportPublic FDA data

Application 050480

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIBRAMYCINDOXYCYCLINE CALCIUMSUSPENSION;ORALEQ 50MG BASE/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0971Vibramycin Calciumdoxycycline calciumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0971Vibramycin Calciumdoxycycline calciumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0971Vibramycin Calciumdoxycycline calciumPfizer Laboratories Div PNDACurrent
0069-0971Vibramycin Calciumdoxycycline calciumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0971Vibramycin Calciumdoxycycline calciumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0971Vibramycin Calciumdoxycycline calciumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0971Vibramycin Calciumdoxycycline calciumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0971Vibramycin Calciumdoxycycline calciumPfizer Laboratories Div Pfizer IncNDACurrent
0069-0971Vibramycin Calciumdoxycycline calciumPfizer Laboratories Div Pfizer IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83084SUPPL 2025-08-12
83080SUPPL 2025-08-11
81846SUPPL 2025-04-08
81790SUPPL 2025-04-02
61438SUPPL2019-12-26
61413SUPPL2019-12-23
56670SUPPL2018-12-07
56627SUPPL2018-12-04
49113SUPPL2017-07-28
49094SUPPL2017-07-27
46591SUPPL2016-12-29
46501SUPPL2016-12-21
17846SUPPL2016-04-07
30046SUPPL2016-04-05
38952SUPPL2014-10-02
7769SUPPL2014-09-16
17845SUPPL2013-09-09
7768SUPPL2013-09-09
17844SUPPL2013-05-01
7767SUPPL2013-04-30
38951SUPPL2011-05-16
38950SUPPL2008-02-14
7766SUPPL2008-02-13
30045SUPPL2004-03-16
7765SUPPL2002-06-18