Application 202632

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDETABLET;ORALEQ 400MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202632-001MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202632-001AB

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-0487673890dc5c…
2021-03-12 10:30 UTC2021-03A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-043f01610625f2…
2019-09-15 20:21 UTC2019-09A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04b00525d2431f…
2019-07-19 19:46 UTC2019-07A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-043f0d92c62455…
2023-05-13 08:27 UTC2023-05A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04053a50430f4f…
2023-01-26 05:58 UTC2023-01A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202632-001MOXIFLOXACIN HYDROCHLORIDEEQ 400MG BASETABLET / ORALAB2014-03-04e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202632-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202632-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202632-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202632-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202632-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202632-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202632-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202632-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202632-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202632-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202632-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202632-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202632-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202632-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202632-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202632-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202632-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202632-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202632-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202632-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202632-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202632-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202632-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202632-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202632-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202632-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202632-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202632-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202632-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202632-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202632-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202632-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202632-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202632-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202632-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202632-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202632-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202632-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202632-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202632-001AB1e64feba35796…

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 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEAmerican Health Packaging1ed191f5-7df5-488c-bb72-91ac0b618d9a2026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
ndc (product): 68084-722
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEREMEDYREPACK INC.bd0c0690-ba48-41c5-b76b-b1a53c36f4242026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEAvPAK371ca7b2-c62d-ef4b-3076-890b385bfff82026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
ndc (product): 50268-576
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.be5b7a6f-9ee3-4453-807e-4761fffff60c2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1a98b20d-c4a1-4184-8387-a4866d1d62bf2026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
ndc (product): 72789-037
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.18b77b31-baf3-416f-b3b7-a631c8e46d202026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
ndc (product): 72789-038
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEBryant Ranch Prepack6cd420c3-113e-4fc2-b59f-bfc7c485c14d2026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEMajor Pharmaceuticals815d71cf-02de-4190-9bd1-3fdc67ef0f062025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEBryant Ranch Prepackac8a81b9-2fed-412a-8c83-db8dee1061f62025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDERising Pharma Holdings, Inc.f34c08e6-fe74-4de3-9e36-a82c3c1c183b2025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
ndc (product): 57237-156
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEA-S Medication Solutions37466c79-8726-4fd6-9412-0bb83d523fe32025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEAurobindo Pharma Limitedd6789c17-4a2f-4519-9060-e3b0dba422f02025-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
ndc (product): 65862-603
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEREMEDYREPACK INC.54377276-96bf-4140-9e90-55623ab6b0132025-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDEA-S Medication Solutions02c29e8e-8346-4e28-b7fc-2f4cb61ad37d2024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632
Moxifloxacin HydrochlorideMOXIFLOXACIN HYDROCHLORIDEA-S Medication Solutionsc71e5987-edd7-4c38-b646-3e48a6e51bf42023-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202632
application number: ANDA202632

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50268-576Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideAvPAKANDACurrent
50268-576Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideAvPAKANDACurrent
50268-576Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideAvPAKANDACurrent
57237-156Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRising Health, LLCANDACurrent
57237-156Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRising Health, LLCANDACurrent
57237-156Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRising Health, LLCANDACurrent
57237-156Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRising Health, LLCANDACurrent
57237-156Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRising Health, LLCANDACurrent
65862-603MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-603MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-603MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-603MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochlorideAurobindo Pharma LimitedANDACurrent
65862-603MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochlorideAurobindo Pharma LimitedANDACurrent
67296-1616Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1616Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1616Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideRedPharm Drug, Inc.ANDACurrent
68084-722Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-722Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-722Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-722Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideAmerican Health PackagingANDACurrent
68084-722Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideAmerican Health PackagingANDACurrent
72789-037MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-037MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-037MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-037MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-038MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-038MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-038MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-038MOXIFLOXACIN HYDROCHLORIDEmoxifloxacin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10088ORIG2014-03-06