FDA.reportPublic FDA data

Application 050442

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIBRAMYCINDOXYCYCLINE HYCLATEINJECTABLE;INJECTIONEQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002VIBRAMYCINDOXYCYCLINE HYCLATEINJECTABLE;INJECTIONEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050442-001VIBRAMYCINDOXYCYCLINE HYCLATEEQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982
N050442-002VIBRAMYCINDOXYCYCLINE HYCLATEEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N050442-001VIBRAMYCINEQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N050442-002VIBRAMYCINEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050442-001VIBRAMYCINEQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N050442-002VIBRAMYCINEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050442-001VIBRAMYCINEQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050442-002VIBRAMYCINEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050442-001VIBRAMYCINEQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050442-002VIBRAMYCINEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, Approved before 1982a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 7 · 139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.051654c7-8ba6-44f2-842c-72f515e9b32d2026-09-15Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
doxycycline hyclateDOXYCYCLINE HYCLATEHAWAII REPACK, INC88c429a1-351d-432e-b69b-d7a0afca482a2026-09-09Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutions9ecadbc8-3087-4692-916a-b7f392d8e8da2026-09-09Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEREMEDYREPACK INC.5fdc01c3-c62f-40cf-8351-91cbcc43d3792026-09-01Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline hyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.df44c686-de34-487a-8741-a0a12993cab22026-08-27Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
DoxycyclineDOXYCYCLINE HYCLATEREMEDYREPACK INC.2c29f716-bdb0-437d-92a4-d856b87db9762026-08-26Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.0106a3d3-db4d-f6ee-e063-6294a90a25e92026-08-26Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
DoxycyclineDOXYCYCLINE HYCLATEAcella Pharmaceuticals, LLC3fb9f5ad-90a2-4858-bc34-f800d8b2fa902026-08-18Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEMajor Pharmaceuticalse7c14a8e-c713-4f03-94e8-1ec9ae077d4d2026-08-05Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.2305ab4a-7d08-41f6-9c39-c9b6835be3892026-08-05Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
DoxycyclineDOXYCYCLINE HYCLATEREMEDYREPACK INC.db53637e-16ac-41b0-b9d5-553471405d642026-08-03Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c2026-07-29Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.3af9348c-a98b-4059-a5ef-4229e2b33af02026-07-20Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.0994d23a-f9e4-4c33-ba44-a1f4ae4a312c2026-07-20Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.1401d590-0967-4c6b-b52b-a83e9f6df0972026-07-17Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.b988f851-cc06-4570-9706-cf65d370bd8e2026-07-17Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.35aa295e-ff1b-453b-8eeb-65bbeda3baa52026-07-17Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycyclate HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.4dc319c1-b7ef-40e4-9e66-fb24cfdefea82026-07-09Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.6e3d0691-c071-441c-9b00-22a3803050662026-07-03Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE
Doxycycline HyclateDOXYCYCLINE HYCLATEChartwell RX, LLCfad03768-f1d2-459f-965e-0ec29f189f1f2026-06-30Warnings, Adverse reactionsName fallback
generic name: DOXYCYCLINE HYCLATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49112SUPPL2017-07-28
49093SUPPL2017-07-27
46590SUPPL2016-12-29
46502SUPPL2016-12-21
17829SUPPL2016-04-07
7744SUPPL2016-04-05
38939SUPPL2014-09-26
30023SUPPL2014-09-25
17828SUPPL2013-09-17
7743SUPPL2013-09-13
7742SUPPL2002-06-18