Application 091118

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 45MG BASENoNo
002MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 55MG BASENoNo
003MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 65MG BASENoNo
004MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 80MG BASENoNo
005MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 90MG BASENoNo
006MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 105MG BASENoNo
007MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 115MG BASENoNo
008MINOCYCLINE HYDROCHLORIDEMINOCYCLINE 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 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091118-001MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 45MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25
A091118-003MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 65MG BASETABLET, EXTENDED RELEASE / ORAL2019-12-03
A091118-004MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 80MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25
A091118-005MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 90MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25
A091118-006MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25
A091118-007MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 115MG BASETABLET, EXTENDED RELEASE / ORAL2019-12-03
A091118-008MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25

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 8 · 295 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091118-001MINOCYCLINE HYDROCHLORIDEEQ 45MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-2584e616aacf4f…
2026-09-14 22:38:342026-08A091118-003MINOCYCLINE HYDROCHLORIDEEQ 65MG BASETABLET, EXTENDED RELEASE / ORAL2019-12-0384e616aacf4f…
2026-09-14 22:38:342026-08A091118-004MINOCYCLINE HYDROCHLORIDEEQ 80MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-2584e616aacf4f…
2026-09-14 22:38:342026-08A091118-005MINOCYCLINE HYDROCHLORIDEEQ 90MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-2584e616aacf4f…
2026-09-14 22:38:342026-08A091118-006MINOCYCLINE HYDROCHLORIDEEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-2584e616aacf4f…
2026-09-14 22:38:342026-08A091118-007MINOCYCLINE HYDROCHLORIDEEQ 115MG BASETABLET, EXTENDED RELEASE / ORAL2019-12-0384e616aacf4f…
2026-09-14 22:38:342026-08A091118-008MINOCYCLINE HYDROCHLORIDEEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-2584e616aacf4f…
2026-08-18 06:07:402026-07A091118-001MINOCYCLINE HYDROCHLORIDEEQ 45MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07A091118-003MINOCYCLINE HYDROCHLORIDEEQ 65MG BASETABLET, EXTENDED RELEASE / ORAL2019-12-03caaa826d4ba7…
2026-08-18 06:07:402026-07A091118-004MINOCYCLINE HYDROCHLORIDEEQ 80MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07A091118-005MINOCYCLINE HYDROCHLORIDEEQ 90MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07A091118-006MINOCYCLINE HYDROCHLORIDEEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25caaa826d4ba7…
2026-08-18 06:07:402026-07A091118-007MINOCYCLINE HYDROCHLORIDEEQ 115MG BASETABLET, EXTENDED RELEASE / ORAL2019-12-03caaa826d4ba7…
2026-08-18 06:07:402026-07A091118-008MINOCYCLINE HYDROCHLORIDEEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091118-001MINOCYCLINE HYDROCHLORIDEEQ 45MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091118-003MINOCYCLINE HYDROCHLORIDEEQ 65MG BASETABLET, EXTENDED RELEASE / ORAL2019-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091118-004MINOCYCLINE HYDROCHLORIDEEQ 80MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091118-005MINOCYCLINE HYDROCHLORIDEEQ 90MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091118-006MINOCYCLINE HYDROCHLORIDEEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091118-007MINOCYCLINE HYDROCHLORIDEEQ 115MG BASETABLET, EXTENDED RELEASE / ORAL2019-12-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091118-008MINOCYCLINE HYDROCHLORIDEEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091118-001MINOCYCLINE HYDROCHLORIDEEQ 45MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091118-003MINOCYCLINE HYDROCHLORIDEEQ 65MG BASETABLET, EXTENDED RELEASE / ORAL2019-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091118-004MINOCYCLINE HYDROCHLORIDEEQ 80MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091118-005MINOCYCLINE HYDROCHLORIDEEQ 90MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091118-006MINOCYCLINE HYDROCHLORIDEEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091118-007MINOCYCLINE HYDROCHLORIDEEQ 115MG BASETABLET, EXTENDED RELEASE / ORAL2019-12-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091118-008MINOCYCLINE HYDROCHLORIDEEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091118-001MINOCYCLINE HYDROCHLORIDEEQ 45MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091118-003MINOCYCLINE HYDROCHLORIDEEQ 65MG BASETABLET, EXTENDED RELEASE / ORAL2019-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091118-004MINOCYCLINE HYDROCHLORIDEEQ 80MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091118-005MINOCYCLINE HYDROCHLORIDEEQ 90MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091118-006MINOCYCLINE HYDROCHLORIDEEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091118-007MINOCYCLINE HYDROCHLORIDEEQ 115MG BASETABLET, EXTENDED RELEASE / ORAL2019-12-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091118-008MINOCYCLINE HYDROCHLORIDEEQ 135MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091118-001MINOCYCLINE HYDROCHLORIDEEQ 45MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091118-003MINOCYCLINE HYDROCHLORIDEEQ 65MG BASETABLET, EXTENDED RELEASE / ORAL2019-12-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091118-004MINOCYCLINE HYDROCHLORIDEEQ 80MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091118-005MINOCYCLINE HYDROCHLORIDEEQ 90MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091118-006MINOCYCLINE HYDROCHLORIDEEQ 105MG BASETABLET, EXTENDED RELEASE / ORAL2014-09-25fd3edfee7708…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 162 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091118-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091118-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091118-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091118-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091118-006AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091118-007AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091118-008AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091118-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091118-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091118-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091118-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091118-006AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091118-007AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091118-008AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091118-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091118-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091118-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091118-005AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091118-006AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091118-007AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091118-008AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091118-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091118-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091118-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091118-006AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091118-008AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091118-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091118-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091118-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091118-005AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091118-006AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091118-007AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091118-008AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091118-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091118-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091118-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091118-005AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091118-006AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091118-007AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091118-008AB1782e0a99824c…

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
brand name: Minocycline Hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack493bdeac-e073-4ec2-a481-85e6a6d3cb582026-03-25Warnings, Adverse reactionsName fallback
brand name: Minocycline Hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack74946a91-b138-42cd-a9d4-58fe8f8492702026-03-25Warnings, Adverse reactionsName fallback
brand name: Minocycline Hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack653b22f3-9eb5-4c29-9b95-bc1c4f0273be2026-03-25Warnings, Adverse reactionsName fallback
brand name: Minocycline Hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepacke1611d28-0c96-4ce2-ad5d-f62f66ec164d2026-03-25Warnings, Adverse reactionsName fallback
brand name: Minocycline Hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackbb3b9a7e-6724-4c2a-b3cb-236f522b31a82026-03-09Warnings, Adverse reactionsName fallback
brand name: Minocycline Hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEA-S Medication Solutionsc96b1c5d-7004-4ee2-ad48-0ba963389f862026-02-19Warnings, Adverse reactionsName fallback
brand name: Minocycline Hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEREMEDYREPACK INC.6597bdc9-9e3a-4c11-8b39-27b47f8632872026-02-04Warnings, Adverse reactionsName fallback
brand name: Minocycline Hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochlorideMINOCYCLINE HYDROCHLORIDENorthwind Health Company, LLC0760232b-21a6-2b13-e063-6394a90a22c12026-01-01Warnings, Adverse reactionsName fallback
brand name: Minocycline hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDENorthwind Health Company, LLC12559b29-6568-4b99-a16e-6a87038981f72026-01-01Warnings, Adverse reactionsName fallback
brand name: Minocycline Hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline hydrochlorideMINOCYCLINE HYDROCHLORIDENorthwind Health Company, LLCf33fcfd2-b9ef-8e67-e053-2a95a90a03062026-01-01Warnings, Adverse reactionsName fallback
brand name: Minocycline hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEAscend Laboratories, LLCa8f95207-b259-4f50-87f2-3652d92688902025-12-18Warnings, Adverse reactionsName fallback
brand name: Minocycline Hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack6b2a7493-2e6c-4901-b697-17eb188cc8dd2025-11-17Warnings, Adverse reactionsName fallback
brand name: Minocycline Hydrochloride
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
brand name: Minocycline Hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack2688e63a-09c7-4d73-a923-cf14fec7b1a42025-07-28Warnings, Adverse reactionsName fallback
brand name: Minocycline Hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackddd22f2c-050b-4776-912b-39b3e6202c752025-07-28Warnings, Adverse reactionsName fallback
brand name: Minocycline Hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEAmerican Health Packaging94d941e3-d3d8-4414-bd5c-4a92848e738f2025-07-25Warnings, Adverse reactionsName fallback
brand name: Minocycline Hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack9f4139e4-d4ab-46ea-a3f1-f719ab57a55e2025-07-03Warnings, Adverse reactionsName fallback
brand name: Minocycline Hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack084fb405-fcb9-4db9-8d95-5a9c1d89f3b62025-07-03Warnings, Adverse reactionsName fallback
brand name: Minocycline Hydrochloride
generic name: MINOCYCLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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