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HYDROCHLORIDECAPSULE;ORALEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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 42.

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HYDROCHLORIDEEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-12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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N050649-001MINOCINEQ 50MG BASECAPSULE / ORALABRLD1990-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07N050649-002MINOCINEQ 100MG BASECAPSULE / ORALABRLD1990-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07N050649-003MINOCINEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2001-02-12caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2021-12-28 21:50 UTC2021-12N050649-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N050649-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050649-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050649-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N050649-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N050649-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050649-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050649-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050649-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N050649-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050649-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N050649-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N050649-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N050649-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N050649-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N050649-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050649-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050649-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050649-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N050649-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050649-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N050649-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050649-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050649-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050649-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050649-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050649-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050649-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050649-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050649-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N050649-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05N050649-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N050649-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N050649-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050649-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050649-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050649-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N050649-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050649-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09N050649-002AB1e64feba35796…

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

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