Application 065334

Type
ANDA
Sponsor
AUROBINDO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLINAMOXICILLINFOR SUSPENSION;ORAL200MG/5MLNoNo
002AMOXICILLINAMOXICILLINFOR SUSPENSION;ORAL400MG/5MLNoNo

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

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
A065334-001AMOXICILLINAMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28
A065334-002AMOXICILLINAMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065334-001AB
A065334-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28caaa826d4ba7…
2026-08-18 06:07:402026-07A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065334-001AMOXICILLIN200MG/5MLFOR SUSPENSION / ORALAB2006-12-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065334-002AMOXICILLIN400MG/5MLFOR SUSPENSION / ORALAB2006-12-28bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A065334-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065334-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065334-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065334-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065334-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065334-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065334-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065334-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065334-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065334-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065334-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065334-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065334-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065334-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065334-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065334-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065334-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065334-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065334-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065334-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065334-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065334-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065334-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065334-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065334-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065334-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065334-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065334-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065334-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065334-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065334-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065334-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065334-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065334-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065334-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065334-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065334-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065334-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065334-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065334-002AB1bb7c543d1eb4…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.573fcf4a-2b87-45d9-ac73-e1dec4fbc28b2026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINREMEDYREPACK INC.2732a8c7-9e4b-43c9-9712-df4b237ab69c2025-11-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AMOXICILLINAMOXICILLINDirectRxcedde8f5-aadd-53de-e053-2995a90aab162025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
ndc (product): 72189-285
AmoxicillinAMOXICILLINRising Pharma Holdings, Inc.554239db-69fe-405a-910a-d9f9e3f8b6ed2024-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
ndc (product): 57237-033
ndc (product): 57237-032
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.97a657a3-8238-f5f1-e053-2a95a90a7a7a2024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
ndc (product): 68071-5109
AmoxicillinAMOXICILLINAurobindo Pharma Limited3cacd754-73f4-496e-a529-9ca39fa6692d2024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
ndc (product): 65862-071
ndc (product): 65862-070
AmoxicillinAMOXICILLINA-S Medication Solutionsd5ecb620-5267-4dcf-be81-64c7766516f52024-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINA-S Medication Solutions3d8a700b-b23b-459a-a19a-213dd39b6a3a2024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
ndc (product): 50090-6323
AmoxicillinAMOXICILLINA-S Medication Solutions1dc5cc5a-59ba-4bc9-b581-cb7b70ce26522024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AMOXICILLINAMOXICILLINDIRECT RX0173e9de-a995-4386-bb65-8fc2bbf347f92024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
ndc (product): 61919-401
AmoxicillinAMOXICILLINProficient Rx LPfcdaba34-373f-4d4e-8203-76f02e3bb00a2024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
ndc (product): 63187-262
AmoxicillinAMOXICILLINProficient Rx LPd5eba477-e255-4d97-9e16-30543c2986802023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
AmoxicillinAMOXICILLINProficient Rx LPe40f3e20-facf-46f4-89c7-3593bc27d0fc2021-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065334
application number: ANDA065334
ndc (product): 63187-335

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 57 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-294AmoxicillinAmoxicillinRebel Distributors Corp.ANDACurrent
33261-463AmoxicillinAmoxicillinAidarex Pharmaceuticals LLCANDACurrent
33261-766AmoxicillinAmoxicillinAidarex Pharmaceuticals LLCANDACurrent
50090-3480AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-4260AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-4260AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-6323AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50436-5101AmoxicillinAmoxicillinUnit Dose ServicesANDACurrent
52959-296AmoxicillinAmoxicillinH.J. Harkins Company, Inc.ANDACurrent
53217-316AmoxicillinAmoxicillinAidarex Pharmaceuticals LLCANDACurrent
55045-2992AmoxicillinAmoxicillinDispensing Solutions Inc.ANDACurrent
55700-468AmoxicillinAmoxicillinLake Erie Medical DBA Quality Care Products LLCANDACurrent
57237-032AmoxicillinAmoxicillinRising Health, LLCANDACurrent
57237-032AmoxicillinAmoxicillinRising Health, LLCANDACurrent
57237-032AmoxicillinAmoxicillinRising Health, LLCANDACurrent
57237-033AmoxicillinAmoxicillinRising Health, LLCANDACurrent
57237-033AmoxicillinAmoxicillinRising Health, LLCANDACurrent
57237-033AmoxicillinAmoxicillinRising Health, LLCANDACurrent
61919-399AMOXICILLINAMOXICILLINDIRECT RXANDACurrent
61919-401AMOXICILLINAMOXICILLINDIRECT RXANDACurrent
61919-401AMOXICILLINAMOXICILLINDIRECT RXANDACurrent
61919-401AMOXICILLINAMOXICILLINDIRECT RXANDACurrent
63187-262AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-262AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-262AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-262AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-335AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-335AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-335AmoxicillinAmoxicillinProficient Rx LPANDACurrent
65862-070AmoxicillinAmoxicillinAurobindo Pharma LimitedANDACurrent
65862-070AmoxicillinAmoxicillinAurobindo Pharma LimitedANDACurrent
65862-070AmoxicillinAmoxicillinAurobindo Pharma LimitedANDACurrent
65862-070AmoxicillinAmoxicillinAurobindo Pharma LimitedANDACurrent
65862-071AmoxicillinAmoxicillinAurobindo Pharma LimitedANDACurrent
65862-071AmoxicillinAmoxicillinAurobindo Pharma LimitedANDACurrent
65862-071AmoxicillinAmoxicillinAurobindo Pharma LimitedANDACurrent
65862-071AmoxicillinAmoxicillinAurobindo Pharma LimitedANDACurrent
68071-2423AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2604AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4189AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4693AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4693AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4693AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4851AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4851AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5109AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5109AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7318AmoxicillinAmoxicillinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7318AmoxicillinAmoxicillinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7318AmoxicillinAmoxicillinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7318AmoxicillinAmoxicillinPreferred Pharmaceuticals Inc.ANDACurrent
68788-9035AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9035AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9035AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9035AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
72189-285AMOXICILLINAMOXICILLINDirectRxANDACurrent
72189-285AMOXICILLINAMOXICILLINDirectRxANDACurrent