Application 065101

Type
ANDA
Sponsor
TEVA

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
A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065101-001AB

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 UTC2026-02A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-303f01610625f2…
2019-09-15 20:21 UTC2019-09A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065101-001AMOXICILLIN AND CLAVULANATE POTASSIUM500MG;EQ 125MG BASETABLET / ORALAB2002-10-30cb3db0bc1861…

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 UTC2026-02A065101-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065101-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065101-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065101-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065101-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065101-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065101-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065101-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065101-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065101-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065101-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065101-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065101-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065101-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065101-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065101-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065101-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065101-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065101-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065101-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065101-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065101-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065101-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065101-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065101-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065101-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065101-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065101-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065101-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065101-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065101-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065101-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065101-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065101-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065101-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065101-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065101-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065101-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065101-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065101-001AB1cb3db0bc1861…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.cc445a39-d84c-4b76-9fb8-ae302e7cd96b2025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065101
application number: ANDA065101
ndc (product): 55289-845
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.0425932a-f6e1-49a6-8480-720f179ace142025-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065101
application number: ANDA065101
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP482511ed-4531-45ec-a4eb-c600aeb033252024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065101
application number: ANDA065101
ndc (product): 63187-327
ndc (product): 63187-032
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMTeva Pharmaceuticals USA, Inc.963e7bea-ff5d-420a-9cb2-e4aefb534b332024-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065101
application number: ANDA065101
ndc (product): 0093-2274
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMAsclemed USA, Inc.8c4125d4-d074-40d4-9def-d3a528fc8c8e2023-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065101
application number: ANDA065101

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-2274Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2274Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2274Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2274Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumTeva Pharmaceuticals USA, Inc.ANDACurrent
21695-214Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumRebel Distributors Corp.ANDACurrent
33261-112Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumAidarex Pharmaceuticals LLCANDACurrent
52959-702Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumH.J. Harkins Company, Inc.ANDACurrent
53002-2390Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-2390Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
53808-0341Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMState of Florida DOH Central PharmacyANDACurrent
55289-845Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-845Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-845Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-845Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-845Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-845Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-845Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-845Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
63187-032Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-032Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-032Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-032Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-032Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-327Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-327Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-327Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-327Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
63187-327Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumProficient Rx LPANDACurrent
68071-1985Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1985Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1985Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3107Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3107Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3107Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4056Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,InANDACurrent
68071-4056Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4056Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8308Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-9055Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent