Application 207146

Type
ANDA
Sponsor
WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMINJECTABLE;INJECTIONEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALNoNo

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

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
A207146-001PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207146-001AP

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-03-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-03-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-03-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-03-173f01610625f2…
2019-09-15 20:21 UTC2019-09A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-03-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAP2017-03-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207146-001PIPERACILLIN AND TAZOBACTAMEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIALINJECTABLE / INJECTIONAPRS2017-03-17e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207146-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207146-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207146-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207146-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207146-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207146-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207146-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207146-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207146-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207146-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207146-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207146-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207146-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207146-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207146-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207146-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207146-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207146-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207146-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207146-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207146-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207146-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A207146-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207146-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207146-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207146-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A207146-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207146-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207146-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207146-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207146-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207146-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207146-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207146-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207146-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207146-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207146-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207146-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207146-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207146-001AP1e64feba35796…

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMWG Critical Care, LLC17a400ae-cbaa-4d07-95f4-c6917dfc05852026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMCivica, Inc.19e89f8b-316b-4dd2-9724-bfe0faeba4082025-12-12Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMCivica, Inc.7aebc0e6-89db-4ef0-b5ab-d6b3199bcfc42025-09-08Warnings, Adverse reactionsName fallback
brand name: piperacillin and tazobactam
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMAvenacy, LLC668a2730-e95a-4639-a506-ae95a6502ca12025-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMEugia US LLC39e19789-de4b-4fd1-ab1c-92f59496f4962025-08-19Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMEugia US LLCa5d8625e-e630-4076-bc55-46ebe861c6a52025-08-08Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMONESOURCE SPECIALTY PHARMA LIMITED28258745-12e4-4f0f-b318-4a1a1bebc9282025-07-21Warnings, Adverse reactionsName fallback
brand name: piperacillin and tazobactam
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMAvenacy, LLC9114cea1-3338-487e-87fa-cc3a409d501a2025-07-07Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMBluePoint Laboratories1aba753c-d0c2-4b35-917a-9143dd4be4682025-06-20Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMApotex Corp.2c8f06a2-49b2-4169-94ef-182d13d248bf2025-05-21Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLCc5cddf50-e486-4ffb-9bc6-ed67ad6bc1542025-04-14Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLCa798faf5-cd97-4e35-a700-94c372978c462025-04-14Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLC6a894b94-171f-4217-81a2-0e84796b0b412025-04-11Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLCc8e3cc43-238d-4a23-95dc-157c85f831842025-04-10Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMProvepharm Inc.68d5384d-1691-4afc-8a1a-488f8e2ef2c52025-02-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam
PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMProvepharm Inc.bc26ffd8-1a6e-4e16-91c1-ec67c928b3bf2025-02-26Warnings, Adverse reactionsName fallback
brand name: PIPERACILLIN AND TAZOBACTAM
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMSandoz Inc9b682c66-61c6-4ade-baf4-9d68911a16b82024-10-30Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMHospira, Inc4d3f4b69-b0b9-494f-9cda-4537fa420d472024-10-25Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMShandong Anxin Pharmaceutical Co., Ltd.420196a5-f62d-473f-84d8-d7fc3f31c3d32024-10-17Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam
Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCfc4d1e35-23eb-4654-8691-ae5bfd50a48a2024-10-16Warnings, Adverse reactionsName fallback
brand name: Piperacillin and Tazobactam

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
22607-679Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumMitim S.r.l.ANDACurrent
64679-679Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumWockhardt USA LLC.ANDACurrent
64679-679Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumWockhardt USA LLC.ANDACurrent
64679-679Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumWockhardt USA LLC.ANDACurrent
64679-679Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumWockhardt USA LLC.ANDACurrent