FDA.reportPublic FDA data

Application 050006

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIBRAMYCINDOXYCYCLINEFOR SUSPENSION;ORALEQ 25MG BASE/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0970Vibramycin MonohydratedoxycyclinePfizer Laboratories Div Pfizer IncNDACurrent
0069-0970Vibramycin MonohydratedoxycyclinePfizer Laboratories Div Pfizer IncNDACurrent
0069-0970Vibramycin MonohydratedoxycyclinePfizer Laboratories Div PNDACurrent
0069-0970Vibramycin MonohydratedoxycyclinePfizer Laboratories Div Pfizer IncNDACurrent
0069-0970Vibramycin MonohydratedoxycyclinePfizer Laboratories Div Pfizer IncNDACurrent
0069-0970Vibramycin MonohydratedoxycyclinePfizer Laboratories Div Pfizer IncNDACurrent
0069-0970Vibramycin MonohydratedoxycyclinePfizer Laboratories Div Pfizer IncNDACurrent
0069-0970Vibramycin MonohydratedoxycyclinePfizer Laboratories Div Pfizer IncNDACurrent
0069-0970Vibramycin MonohydratedoxycyclinePfizer Laboratories Div Pfizer IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83082SUPPL 2025-08-12
83078SUPPL 2025-08-11
81844SUPPL 2025-04-08
81788SUPPL 2025-04-02
61436SUPPL2019-12-26
61408SUPPL2019-12-23
56668SUPPL2018-12-07
56626SUPPL2018-12-04
49110SUPPL2017-07-28
49091SUPPL2017-07-27
46588SUPPL2016-12-29
46504SUPPL2016-12-21
38905SUPPL2016-04-07
29971SUPPL2016-04-05
38904SUPPL2014-10-02
7684SUPPL2014-09-16
17790SUPPL2013-09-09
7683SUPPL2013-09-09
17789SUPPL2013-05-01
7682SUPPL2013-04-30
38903SUPPL2011-05-16
17788SUPPL2008-02-14
29970SUPPL2008-02-13
29969SUPPL2004-03-16
29968SUPPL2002-06-18