Application 209269

Type
NDA
Sponsor
EPI HLTH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MINOLIRAMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 105MG BASENoNo
002MINOLIRAMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 135MG BASENoNo

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

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
N209269-001MINOLIRAMINOCYCLINE HYDROCHLORIDEEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-08
N209269-002MINOLIRAMINOCYCLINE HYDROCHLORIDEEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-08

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209269-001111035172036-04-07Drug product2021-09-02
N209269-002111035172036-04-07Drug product2021-09-02

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0884e616aacf4f…
2026-09-14 22:38:342026-08N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0884e616aacf4f…
2026-08-18 06:07:402026-07N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-08caaa826d4ba7…
2026-08-18 06:07:402026-07N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORALRS2017-05-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORALRS2017-05-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORALRS2017-05-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORALRS2017-05-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORALRS2017-05-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORALRS2017-05-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209269-001MINOLIRAEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N209269-002MINOLIRAEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2017-05-0874a2ff9319b5…

Observed Orange Book patent history#

Patent history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N209269-001111035172036-04-07Drug product2021-09-0284e616aacf4f…
2026-09-14 22:38:342026-08N209269-002111035172036-04-07Drug product2021-09-0284e616aacf4f…
2026-08-18 06:07:402026-07N209269-001111035172036-04-07Drug product2021-09-02caaa826d4ba7…
2026-08-18 06:07:402026-07N209269-002111035172036-04-07Drug product2021-09-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209269-001111035172036-04-07Drug product2021-09-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209269-002111035172036-04-07Drug product2021-09-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209269-001111035172036-04-07Drug product2021-09-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209269-002111035172036-04-07Drug product2021-09-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N209269-001111035172036-04-07Drug product2021-09-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209269-002111035172036-04-07Drug product2021-09-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209269-001111035172036-04-07Drug product2021-09-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209269-002111035172036-04-07Drug product2021-09-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209269-001111035172036-04-07Drug product2021-09-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209269-002111035172036-04-07Drug product2021-09-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209269-001111035172036-04-07Drug product2021-09-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209269-002111035172036-04-07Drug product2021-09-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209269-001111035172036-04-07Drug product2021-09-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209269-002111035172036-04-07Drug product2021-09-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209269-001111035172036-04-07Drug product2021-09-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209269-002111035172036-04-07Drug product2021-09-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209269-001111035172036-04-07Drug product2021-09-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209269-002111035172036-04-07Drug product2021-09-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209269-001111035172036-04-07Drug product2021-09-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N209269-002111035172036-04-07Drug product2021-09-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209269-001111035172036-04-07Drug product2021-09-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209269-002111035172036-04-07Drug product2021-09-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209269-001111035172036-04-07Drug product2021-09-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209269-002111035172036-04-07Drug product2021-09-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209269-001111035172036-04-07Drug product2021-09-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209269-002111035172036-04-07Drug product2021-09-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209269-001111035172036-04-07Drug product2021-09-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05N209269-002111035172036-04-07Drug product2021-09-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209269-001111035172036-04-07Drug product2021-09-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209269-002111035172036-04-07Drug product2021-09-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209269-001111035172036-04-07Drug product2021-09-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N209269-002111035172036-04-07Drug product2021-09-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209269-001111035172036-04-07Drug product2021-09-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N209269-002111035172036-04-07Drug product2021-09-024b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N209269-001111035172036-04-07Drug product2021-09-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N209269-002111035172036-04-07Drug product2021-09-02bb7c543d1eb4…

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 2 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack74946a91-b138-42cd-a9d4-58fe8f8492702026-03-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack653b22f3-9eb5-4c29-9b95-bc1c4f0273be2026-03-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepacke1611d28-0c96-4ce2-ad5d-f62f66ec164d2026-03-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackbb3b9a7e-6724-4c2a-b3cb-236f522b31a82026-03-09Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEA-S Medication Solutionsc96b1c5d-7004-4ee2-ad48-0ba963389f862026-02-19Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEREMEDYREPACK INC.6597bdc9-9e3a-4c11-8b39-27b47f8632872026-02-04Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochlorideMINOCYCLINE HYDROCHLORIDENorthwind Health Company, LLC0760232b-21a6-2b13-e063-6394a90a22c12026-01-01Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDENorthwind Health Company, LLC12559b29-6568-4b99-a16e-6a87038981f72026-01-01Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochlorideMINOCYCLINE HYDROCHLORIDENorthwind Health Company, LLCf33fcfd2-b9ef-8e67-e053-2a95a90a03062026-01-01Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEAscend Laboratories, LLCa8f95207-b259-4f50-87f2-3652d92688902025-12-18Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack6b2a7493-2e6c-4901-b697-17eb188cc8dd2025-11-17Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
MinocinMINOCYCLINE HYDROCHLORIDEMelinta Therapeutics, LLCe415c323-8219-464b-9e3e-72c5a796cdaa2025-09-11Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepacke69284bc-0479-48d0-beb5-a26cfad6cd762025-08-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack2688e63a-09c7-4d73-a923-cf14fec7b1a42025-07-28Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackddd22f2c-050b-4776-912b-39b3e6202c752025-07-28Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEAmerican Health Packaging94d941e3-d3d8-4414-bd5c-4a92848e738f2025-07-25Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack9f4139e4-d4ab-46ea-a3f1-f719ab57a55e2025-07-03Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack084fb405-fcb9-4db9-8d95-5a9c1d89f3b62025-07-03Warnings, Adverse reactionsName fallback
generic name: MINOCYCLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-539MinoliraMinoliraDr. Reddys Laboratories IncNDACurrent
43598-540MinoliraMinoliraDr. Reddys Laboratories IncNDACurrent
71403-101Minolira Extended ReleaseMinocycline HydrochlorideEPI Health, IncNDACurrent
71403-101Minolira Extended ReleaseMinocycline HydrochlorideEPI Health, IncNDACurrent
71403-101Minolira Extended ReleaseMinocycline HydrochlorideEPI Health, IncNDACurrent
71403-101Minolira Extended ReleaseMinocycline HydrochlorideEPI Health, IncNDACurrent
71403-102Minolira Extended ReleaseMinocycline HydrochlorideEPI Health, IncNDACurrent
71403-102Minolira Extended ReleaseMinocycline HydrochlorideEPI Health, IncNDACurrent
71403-102Minolira Extended ReleaseMinocycline HydrochlorideEPI Health, IncNDACurrent
71403-102Minolira Extended ReleaseMinocycline HydrochlorideEPI Health, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54737ORIG2018-07-02