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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N050006-001VIBRAMYCINDOXYCYCLINEEQ 25MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD, Approved before 1982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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N050006-001VIBRAMYCINEQ 25MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSION / ORALRLD, Approved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 5 · 97 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doxycyclineDOXYCYCLINEPreferred Pharmaceuticals Inc.bcc95094-80ed-4023-b2a6-955a4810bfbe2026-07-30Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEWellhouse Pharma, LLC57f97f68-11fb-4900-9efb-ca3b00818d8e2026-07-24Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEBryant Ranch Prepack04de98f3-33a2-48ba-85b5-9fac867524b72026-07-15Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEGolden State Medical Supply, Inc.e9997efa-9ad8-3870-e053-2a95a90a1ac32026-07-06Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DOXYCYCLINEDOXYCYCLINEREMEDYREPACK INC.fa2d9328-b688-47af-8c4d-dc328cf353922026-06-24Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEStrides Pharma Science Limited9e710113-f25e-46fb-8327-7a8e649613a22026-06-10Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEA-S Medication Solutions55873d3e-09c4-4726-acfe-5da5815895752026-05-22Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
doxycyclineDOXYCYCLINEREMEDYREPACK INC.d3c0b756-30ba-4ef9-a178-fd785d7203732026-05-20Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
doxycyclineDOXYCYCLINEREMEDYREPACK INC.f0fbf63a-e75c-40cf-b2e9-429deaac899d2026-05-06Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
doxycyclineDOXYCYCLINEST. MARY'S MEDICAL PARK PHARMACY00b2aa98-dea2-90c3-e063-6294a90a35d62026-05-01Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEAmerican Health Packaginge49f8ff9-af7a-47eb-929b-238cff381c032026-04-29Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
doxycyclineDOXYCYCLINEPreferred Pharmaceuticals Inc.7f882f1a-fe75-4592-9df5-f0e4bf1d232e2026-04-08Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEMeitheal Pharmaceuticals Inc.7772e702-20b3-473a-8bd5-9c7c92e753c62026-04-07Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
doxycyclineDOXYCYCLINEPD-Rx Pharmaceuticals, Inc.7028b7f9-21cd-4c8e-97aa-a3e7d849939b2026-03-27Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
doxycyclineDOXYCYCLINEPD-Rx Pharmaceuticals, Inc.dedebcb4-3c3f-4487-a488-36af12640c922026-03-25Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DOXYCYCLINEDOXYCYCLINEDIRECT RX31512ece-cb16-2a9a-e054-00144ff88e882026-03-05Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEProficient Rx LPd9388b32-dcb8-4dff-8a35-8fccb31bd1f82026-03-01Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
DoxycyclineDOXYCYCLINEAmerican Health Packaging3fbf4bb8-036e-41d3-9628-476fc05ddd312026-02-23Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
doxycyclineDOXYCYCLINEA-S Medication Solutions1c998ca8-1df6-4b3c-9533-f4500cc1079a2026-02-10Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE
doxycyclineDOXYCYCLINEA-S Medication Solutions2c7795c9-9e4e-477a-ad9f-01e4c55c06b62026-02-10Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE

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
0069-0970Vibramycin 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