Application 065322

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLINAMOXICILLINFOR SUSPENSION;ORAL250MG/5MLNoNo
002AMOXICILLINAMOXICILLINFOR SUSPENSION;ORAL125MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A065322-001AMOXICILLINAMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19
A065322-002AMOXICILLINAMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065322-001AB
A065322-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065322-001AMOXICILLIN250MG/5MLFOR SUSPENSION / ORALAB2006-06-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A065322-002AMOXICILLIN125MG/5MLFOR SUSPENSION / ORALAB2006-06-19782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065322-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065322-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065322-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065322-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065322-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065322-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065322-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065322-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065322-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065322-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065322-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065322-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065322-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065322-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065322-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065322-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065322-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065322-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065322-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065322-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065322-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065322-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065322-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065322-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065322-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065322-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065322-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065322-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065322-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065322-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065322-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065322-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065322-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065322-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065322-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065322-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065322-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065322-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065322-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065322-002AB1782e0a99824c…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINA-S Medication Solutions60c7ae87-9631-4b29-9ca4-82fb3bafcab82026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
ndc (product): 50090-0404
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.bd46de4c-4571-ba9a-e053-2a95a90a792d2026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
ndc (product): 68071-2364
AmoxicillinAMOXICILLINA-S Medication Solutions8bce45db-dea7-4090-9d64-8b11b08d963e2026-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
ndc (product): 50090-0405
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.0ce05282-995c-461e-b807-facb1fcbb4052026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.9cad7ff5-5151-47d9-bc66-2ded25deefc22025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.54c1d2a4-fe96-6efb-e054-00144ff88e882025-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
ndc (product): 66267-993
AmoxilAMOXICILLIN ORAL SUSPDirectRxec7dd735-dc92-3d29-e053-2a95a90af5492025-01-22Warnings, Adverse reactionsExact identifier
ndc (product): 72189-385
AmoxicillinAMOXICILLINA-S Medication Solutions5b2a2e62-6fd2-4ab1-b936-8702e68233fa2025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
ndc (product): 50090-0406
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.5f8b3c58-ed9f-84a2-e053-2a91aa0ac8cf2024-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
ndc (product): 68071-1760
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.5c60cb1c-3baf-3af2-e053-2a91aa0ae2082024-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
ndc (product): 68071-1761
AmoxicillinAMOXICILLINA-S Medication Solutions0b5acc3f-c474-4b16-9d66-8048abb3b22d2024-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
ndc (product): 50090-0411
AmoxicillinAMOXICILLINNuCare Pharmaceuticals Inc.2177c68d-2884-ce70-e063-6294a90aa2672024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
AmoxicillinAMOXICILLINProficient Rx LP6a9cfa97-3715-4b75-a1e3-932a34a942d42024-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
ndc (product): 63187-295
AmoxicillinAMOXICILLINHikma Pharmaceuticals USA Inc.077f4a65-3cfb-4cb1-99f2-e27ffc5939c02024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
ndc (product): 0143-9888
ndc (product): 0143-9889
AmoxicillinAMOXICILLINA-S Medication Solutionsca2886d0-7be7-4d41-bad5-df3ad44e0e7e2023-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
ndc (product): 50090-0407
AmoxicillinAMOXICILLINA-S Medication Solutions6c7bccff-00bf-46b0-a9ee-eb27d38d73772023-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
ndc (product): 50090-2251
AmoxicillinAMOXICILLINProficient Rx LP9cac2bf2-fb48-4e83-b953-61c4d55f7e192022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065322
application number: ANDA065322
ndc (product): 63187-029

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 52 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9888AmoxicillinAmoxicillinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9888AmoxicillinAmoxicillinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9888AmoxicillinAmoxicillinWest-Ward Pharmaceuticals CorpANDACurrent
0143-9889AmoxicillinAmoxicillinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9889AmoxicillinAmoxicillinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9889AmoxicillinAmoxicillinWest-Ward Pharmaceuticals CorpANDACurrent
33261-460AmoxicillinAmoxicillinAidarex Pharmaceuticals LLCANDACurrent
33261-602AmoxicillinAmoxicillinAidarex Pharmaceuticals LLCANDACurrent
33261-726AmoxicillinAmoxicillinAidarex Pharmaceuticals LLCANDACurrent
50090-0404AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0405AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0405AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0406AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0407AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0407AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-0411AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-2251AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
50090-2251AmoxicillinAmoxicillinA-S Medication SolutionsANDACurrent
52959-613AmoxicillinAmoxicillinH.J. Harkins Company, Inc.ANDACurrent
59115-044AmoxicillinAmoxicillinHikma PharmaceuticalANDACurrent
59115-046AmoxicillinAmoxicillinHikma PharmaceuticalANDACurrent
61919-015AMOXICILLINAMOXICILLINDIRECT RXANDACurrent
61919-015AMOXICILLINAMOXICILLINDIRECT RXANDACurrent
61919-716AMOXILAMOXICILLINDirect_RxANDACurrent
61919-716AMOXILAMOXICILLINDirect_RxANDACurrent
63187-029AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-029AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-029AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-195AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-195AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-295AmoxicillinAmoxicillinProficient Rx LPANDACurrent
63187-295AmoxicillinAmoxicillinProficient Rx LPANDACurrent
66267-993AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
66267-993AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1760AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1760AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1760AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1761AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1761AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1761AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2364AmoxicillinAmoxicillinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9017AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9017AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9017AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9017AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9017AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9019AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9019AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9019AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9019AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9019AmoxicillinAmoxicillinPreferred Pharmaceuticals, Inc.ANDACurrent
72189-385AmoxilAmoxicillin Oral SuspDirectRxANDACurrent