Application 077921

Type
ANDA
Sponsor
ZYDUS PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MELOXICAMMELOXICAMTABLET;ORAL7.5MGNoNo
002MELOXICAMMELOXICAMTABLET;ORAL15MGNoNo

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
A077921-001MELOXICAMMELOXICAM7.5MGTABLET / ORALAB2006-07-19
A077921-002MELOXICAMMELOXICAM15MGTABLET / ORALABRS2006-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077921-001AB
A077921-002AB

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-1984e616aacf4f…
2026-08-18 06:07:402026-07A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077921-002MELOXICAM15MGTABLET / ORALABRS2006-07-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077921-002MELOXICAM15MGTABLET / ORALAB2006-07-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077921-002MELOXICAM15MGTABLET / ORALAB2006-07-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077921-002MELOXICAM15MGTABLET / ORALAB2006-07-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077921-001MELOXICAM7.5MGTABLET / ORALAB2006-07-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077921-002MELOXICAM15MGTABLET / ORALAB2006-07-1974a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077921-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077921-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A077921-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077921-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077921-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077921-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077921-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077921-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077921-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077921-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077921-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077921-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077921-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077921-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077921-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077921-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077921-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077921-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077921-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077921-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077921-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077921-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077921-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077921-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077921-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077921-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077921-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077921-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077921-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077921-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077921-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077921-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077921-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077921-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077921-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077921-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077921-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077921-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077921-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077921-002AB174a2ff9319b5…

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
meloxicamMELOXICAMA-S Medication Solutionsbcfca8c6-bdba-4546-97be-1fc5601c73462023-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
ndc (product): 50090-5340
meloxicamMELOXICAMAphena Pharma Solutions - Tennessee, LLC10c3949c-0066-4b8a-8d35-937e1ce09bf82021-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
ndc (product): 71610-580
meloxicamMELOXICAMAphena Pharma Solutions - Tennessee, LLC966ae650-ad7d-4de1-ab06-54992408fcfd2021-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077921
application number: ANDA077921
ndc (product): 71610-516

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 2 · 85 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7885MeloxicamMeloxicamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7886meloxicammeloxicamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42708-037MeloxicamMeloxicamQPharma IncANDACurrent
42708-037meloxicammeloxicamQPharma IncANDACurrent
42708-038MeloxicamMeloxicamQPharma IncANDACurrent
42708-038meloxicammeloxicamQPharma IncANDACurrent
50090-5339meloxicammeloxicamA-S Medication SolutionsANDACurrent
50090-5340meloxicammeloxicamA-S Medication SolutionsANDACurrent
50090-5861meloxicammeloxicamA-S Medication SolutionsANDACurrent
50090-5861meloxicammeloxicamA-S Medication SolutionsANDACurrent
54458-964MeloxicamMeloxicamInternational Laboratories, LLCANDACurrent
54458-964MeloxicamMeloxicamInternational Laboratories, LLCANDACurrent
54458-965MeloxicamMeloxicamInternational Laboratories, LLCANDACurrent
54458-965MeloxicamMeloxicamInternational Laboratories, LLCANDACurrent
60687-199MeloxicamMeloxicamAmerican Health PackagingANDACurrent
60687-199MeloxicamMeloxicamAmerican Health PackagingANDACurrent
60687-199MeloxicamMeloxicamAmerican Health PackagingANDACurrent
60687-199MeloxicamMeloxicamAmerican Health PackagingANDACurrent
60760-448meloxicammeloxicamSt. Mary's Medical Park PharmacyANDACurrent
60760-448meloxicammeloxicamSt. Mary's Medical Park PharmacyANDACurrent
60760-448meloxicammeloxicamSt. Mary's Medical Park PharmacyANDACurrent
60760-448meloxicammeloxicamSt. Mary's Medical Park PharmacyANDACurrent
63629-6706meloxicammeloxicamBryant Ranch PrepackANDACurrent
63629-6706meloxicammeloxicamBryant Ranch PrepackANDACurrent
63739-701meloxicammeloxicamMcKesson CorporationANDACurrent
63739-701meloxicammeloxicamMcKesson Corporation dba SKY PackagingANDACurrent
63739-701meloxicammeloxicamMcKesson Corporation dba SKY PackagingANDACurrent
65841-050meloxicammeloxicamCadila Healthcare LimitedANDACurrent
65841-050meloxicammeloxicamCadila Healthcare LimitedANDACurrent
65841-050meloxicammeloxicamZydus Lifesciences LimitedANDACurrent
65841-050meloxicammeloxicamCadila Healthcare LimitedANDACurrent
65841-051meloxicammeloxicamCadila Healthcare LimitedANDACurrent
65841-051meloxicammeloxicamCadila Healthcare LimitedANDACurrent
65841-051meloxicammeloxicamZydus Lifesciences LimitedANDACurrent
65841-051meloxicammeloxicamCadila Healthcare LimitedANDACurrent
66116-403meloxicammeloxicamMedVantx, Inc.ANDACurrent
66116-404meloxicammeloxicamMedVantx, Inc.ANDACurrent
67296-1817meloxicammeloxicamRedPharm Drug, Inc.ANDACurrent
67296-1817meloxicammeloxicamRedPharm Drug, Inc.ANDACurrent
68071-3030meloxicammeloxicamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3030meloxicammeloxicamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4987meloxicammeloxicamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4987meloxicammeloxicamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4987meloxicammeloxicamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4987meloxicammeloxicamNuCare Pharmaceuticals,Inc.ANDACurrent
68151-4319meloxicammeloxicamCarilion Materials ManagementANDACurrent
68382-050meloxicammeloxicamZydus Pharmaceuticals USA Inc.ANDACurrent
68382-050meloxicammeloxicamZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-050meloxicammeloxicamZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-050meloxicammeloxicamZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-050meloxicammeloxicamZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-051meloxicammeloxicamZydus Pharmaceuticals USA Inc.ANDACurrent
68382-051meloxicammeloxicamZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-051meloxicammeloxicamZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-051meloxicammeloxicamZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-051meloxicammeloxicamZydus Pharmaceuticals (USA) Inc.ANDACurrent
68788-7726meloxicammeloxicamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7726meloxicammeloxicamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7726meloxicammeloxicamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7904meloxicammeloxicamPreferred Pharmaceuticals Inc.ANDACurrent
68788-7904meloxicammeloxicamPreferred Pharmaceuticals Inc.ANDACurrent
68788-9897meloxicammeloxicamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9898meloxicammeloxicamPreferred Pharmaceuticals, Inc.ANDACurrent
70518-1828meloxicammeloxicamREMEDYREPACK INC.ANDACurrent
70518-1828meloxicammeloxicamREMEDYREPACK INC.ANDACurrent
70518-1828meloxicammeloxicamREMEDYREPACK INC.ANDACurrent
70518-1828meloxicammeloxicamREMEDYREPACK INC.ANDACurrent
70518-1828meloxicammeloxicamREMEDYREPACK INC.ANDACurrent
70518-1828meloxicammeloxicamREMEDYREPACK INC.ANDACurrent
70518-3023meloxicammeloxicamREMEDYREPACK INC.ANDACurrent
70518-3023meloxicammeloxicamREMEDYREPACK INC.ANDACurrent
70518-3023meloxicammeloxicamREMEDYREPACK INC.ANDACurrent
70518-3023meloxicammeloxicamREMEDYREPACK INC.ANDACurrent
70518-3023meloxicammeloxicamREMEDYREPACK INC.ANDACurrent
70518-3023meloxicammeloxicamREMEDYREPACK INC.ANDACurrent
71335-1956meloxicammeloxicamBryant Ranch PrepackANDACurrent
71335-2080meloxicammeloxicamBryant Ranch PrepackANDACurrent
71610-516meloxicammeloxicamAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-580meloxicammeloxicamAphena Pharma Solutions - Tennessee, LLCANDACurrent
80425-0042MobicMeloxicam 7.5mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31301ORIG2009-05-18