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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050480-001VIBRAMYCINDOXYCYCLINE CALCIUMEQ 50MG BASE/5MLSUSPENSION / ORALRLD, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N050480-001VIBRAMYCINEQ 50MG BASE/5MLSUSPENSION / ORALRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050480-001VIBRAMYCINEQ 50MG BASE/5MLSUSPENSION / ORALRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050480-001VIBRAMYCINEQ 50MG BASE/5MLSUSPENSION / ORALRLD, RS, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050480-001VIBRAMYCINEQ 50MG BASE/5MLSUSPENSION / ORALRLD, Approved before 1982a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

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