Application 050649

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MINOCINMINOCYCLINE HYDROCHLORIDECAPSULE;ORALEQ 50MG BASEYesNo
002MINOCINMINOCYCLINE HYDROCHLORIDECAPSULE;ORALEQ 100MG BASEYesNo
003MINOCINMINOCYCLINE HYDROCHLORIDECAPSULE;ORALEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050649-001MINOCINMINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALABRLD1990-05-31
N050649-002MINOCINMINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALABRLD1990-05-31
N050649-003MINOCINMINOCYCLINE HYDROCHLORIDEEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N050649-001AB
N050649-002AB

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 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-318072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N050649-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050649-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050649-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050649-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050649-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050649-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050649-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050649-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050649-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050649-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050649-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050649-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050649-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050649-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050649-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050649-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050649-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050649-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050649-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050649-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050649-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050649-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050649-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050649-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050649-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050649-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050649-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050649-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050649-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050649-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050649-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050649-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050649-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050649-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050649-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050649-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050649-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050649-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050649-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N050649-002AB1782e0a99824c…

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 4 · 71 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack99825095-d897-4077-86df-483d505615b22026-03-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack493bdeac-e073-4ec2-a481-85e6a6d3cb582026-03-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16781-400Minocinminocycline hydrochlorideOnset Dermatologics LLCNDACurrent
16781-400Minocinminocycline hydrochlorideBausch Health US, LLCNDACurrent
16781-403Minocinminocycline hydrochlorideOnset Dermatologics LLCNDACurrent
16781-403Minocinminocycline hydrochlorideBausch Health US, LLCNDACurrent
43353-172Minocinminocycline hydrochlorideAphena Pharma Solutions - Tennessee, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81853SUPPL 2025-04-08
81793SUPPL 2025-04-02
79144SUPPL 2024-07-22
79129SUPPL 2024-07-22
49037SUPPL2017-07-21
49025SUPPL2017-07-20
46175SUPPL2016-12-15
46189SUPPL2016-12-14
39073SUPPL2015-03-26
30224SUPPL2015-03-11
17973SUPPL2010-09-20
30223SUPPL2010-09-17
7935SUPPL2008-07-01
39072SUPPL2008-06-30
30222SUPPL2007-06-04
7933SUPPL2007-04-09
17972SUPPL2007-04-06
7934SUPPL2007-02-02
39071SUPPL2007-01-25
7932SUPPL2005-10-20
30220SUPPL2005-02-17
42664SUPPL2004-06-29
30221SUPPL2004-06-01
7931SUPPL2004-06-01
7930SUPPL2002-05-31
7929SUPPL2002-02-01
7928SUPPL2002-02-01