FDA.reportPublic FDA data

Application 050445

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MINOCINMINOCYCLINE HYDROCHLORIDESUSPENSION;ORALEQ 50MG BASE/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N050445-001MINOCINMINOCYCLINE HYDROCHLORIDEEQ 50MG BASE/5MLSUSPENSION / ORALApproved 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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N050445-001MINOCINEQ 50MG BASE/5MLSUSPENSION / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050445-001MINOCINEQ 50MG BASE/5MLSUSPENSION / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050445-001MINOCINEQ 50MG BASE/5MLSUSPENSION / ORALApproved 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 4 · 71 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3e74e8a3-2670-97f5-e063-6394a90a361e2026-08-03Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3e796794-b731-61d6-e063-6394a90aa9b32026-07-31Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEMajor Pharamceuticalsfd86ff45-37d0-4501-b9fb-e1836e4a8be42026-07-16Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.caa99901-467c-4e99-b7e9-fbabdf5d118c2026-07-08Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEREMEDYREPACK INC.0becbde8-6ec5-4830-a0d9-cfdb7b15eb842026-07-03Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack093ff3c7-3ecc-47b4-9ae6-5218bcd262b22026-06-26Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack65767ae3-b1ed-4492-90f2-703b2c7e0f382026-06-24Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.87a137c6-dd53-44d3-ab49-ef78ebed35c82026-06-12Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1ec20539-0421-4eac-95ed-e9acc6329fd02026-06-12Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7e2390b7-242c-43ff-afb3-b0a5e79351d32026-05-13Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackc11bfea8-6079-44ce-b8e1-20bfba631bec2026-05-04Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack6e0efd1a-5a09-4030-8fe2-f98334cdeb0e2026-04-22Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack9c43389b-dc98-41f3-80bf-73d916ad68432026-04-22Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEA-S Medication Solutionsc7d0226e-5ac5-4fb1-9849-9d6663a2e8ad2026-04-17Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackbae17358-1180-4ca8-b163-f9a6f4f83a3d2026-04-09Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETorrent Pharmaceuticals Limited3539f84e-b489-4914-96c1-ac37310329712026-04-08Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDETorrent Pharmaceuticals Limited55df55fb-18ec-4e00-9ed0-10bba0da513b2026-04-02Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack409dddb0-be3a-4ae3-ab39-88a6cd50a2192026-03-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackb3236a5c-8a5d-4d5d-9656-aee72a4c482b2026-03-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepacka16012ce-5754-4177-bfb7-dcce696a71892026-03-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81850SUPPL 2025-04-08
81807SUPPL 2025-04-02
79145SUPPL 2024-07-22
79131SUPPL 2024-07-22
56525SUPPL2018-11-20
56511SUPPL2018-11-20
38943SUPPL2015-03-02
30035SUPPL2015-02-27
17836SUPPL2010-09-20
7758SUPPL2010-09-16
38942SUPPL2007-01-18
30034SUPPL2007-01-18
30033SUPPL2005-10-20
17835SUPPL2005-09-30
30031SUPPL2005-02-17
42643SUPPL2004-06-29
30032SUPPL2004-06-01
7757SUPPL2004-06-01
7756SUPPL2002-05-31
30030SUPPL2002-02-01
30029SUPPL2002-02-01
7755SUPPL2002-02-01
7754SUPPL2002-02-01