Application 065064

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET;ORAL500MG;EQ 125MG BASENoNo

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

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
A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065064-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-153f01610625f2…
2019-09-15 20:21 UTC2019-09A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065064-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-03-15cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065064-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065064-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065064-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065064-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065064-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065064-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065064-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065064-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065064-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065064-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065064-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065064-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065064-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065064-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065064-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065064-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065064-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065064-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065064-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065064-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065064-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065064-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065064-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065064-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065064-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065064-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065064-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065064-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065064-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065064-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065064-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065064-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065064-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065064-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065064-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065064-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065064-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065064-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065064-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065064-001AB1cb3db0bc1861…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepack22cd4e96-2288-470c-9264-8058cd7db9b02025-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065064
application number: ANDA065064
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackf748b118-6d50-487a-824d-1c92ab2028c02025-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065064
application number: ANDA065064
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSandoz Inc7cba82f0-9886-46e9-8dbd-43a448aade292025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065064
application number: ANDA065064
ndc (product): 0781-1831
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMDirectRxcdc6d30a-754e-6672-e053-2a95a90afa7f2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065064
application number: ANDA065064
ndc (product): 72189-281
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAsclemed USA, Inc.a94cfba3-27ed-46a3-81ef-e9b80187c2072024-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065064
application number: ANDA065064
ndc (product): 76420-507
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepack71812ac4-9264-49f2-b9ab-ea1efd1af4522024-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065064
application number: ANDA065064
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP01b30abb-db63-4257-9fe2-9107bb0bd69c2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065064
application number: ANDA065064
ndc (product): 63187-803

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-1831Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1831Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1831Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1831Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1831Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
16714-477Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
16714-477Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
16714-477Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
16714-477Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNorthstar RxLLCANDACurrent
43858-606Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
43858-606Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz GmbHANDACurrent
55700-375Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-375Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-375Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-803Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-803Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
68071-2630Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7965Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7965Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-9316Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
69452-336Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumBionpharma Inc.ANDACurrent
69452-336Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumBionpharma Inc.ANDACurrent
70518-3523Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumREMEDYREPACK INC.ANDACurrent
72189-281AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMDirectRxANDACurrent
72189-281AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMDirectRxANDACurrent
76420-507Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumAsclemed USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8382ORIG2002-03-15