Application 061410

Type
ANDA
Sponsor
APOTHECON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VEETIDSPENICILLIN V POTASSIUMFOR SOLUTION;ORALEQ 125MG BASE/5MLNoNo
002VEETIDSPENICILLIN V POTASSIUMFOR SOLUTION;ORALEQ 250MG BASE/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A061410-001VEETIDSPENICILLIN V POTASSIUMEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982
A061410-002VEETIDSPENICILLIN V POTASSIUMEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 1982

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 198287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 19825aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 19828869cabd3fbd…
2020-12-22 03:56 UTC2020-12A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982c0c555d07b60…
2020-11-12 02:37 UTC2020-11A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 19823f01610625f2…
2019-12-14 00:12 UTC2019-12A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982b00525d2431f…
2019-09-15 20:21 UTC2019-09A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982ea99ee380514…
2019-07-19 19:46 UTC2019-07A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 19826a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982053a50430f4f…
2023-05-13 08:27 UTC2023-05A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 19823bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A061410-001VEETIDSEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 19823a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A061410-002VEETIDSEQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 19823a93d1ddd44b…

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 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.dd8a48b2-9ff1-49de-a53e-db4964c2384c2026-09-03Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals,Inc.861ccfaa-8b7a-0def-e053-2991aa0a1a392026-08-21Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMRedpharm Drug58e6fd2f-e595-f788-e063-6394a90a0ea22026-08-13Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPreferred Pharmaceuticals, Inc8c342c78-47fb-4f6b-9451-68b1f752555c2026-08-12Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPreferred Pharmaceuticals Inc.56192625-0564-4131-94b2-8b9c6a0b53b02026-08-12Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.5f0759cc-c553-49b9-9049-80e7137589582026-08-07Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.fba1ffe5-809a-495b-bf3e-f2099ac459f62026-07-28Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.8f9fa2c8-4d25-48a8-9257-43c33d08e83a2026-07-28Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.b5972712-f735-46ed-a94a-b84668bb6a822026-07-24Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMChartwell RX, LLCb0744674-ddf7-4022-be2f-2a22bef0d3792026-07-23Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMRedpharm Drug546c367a-c786-8326-e063-6294a90ae76c2026-07-14Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMProficient Rx LPb8f797fb-979c-4eab-a3a6-ad4edcb9ff072026-06-01Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMBryant Ranch Prepack609c3e26-9220-4f3c-b393-a2b41b68de6c2026-03-12Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMQPharma Inc8c11af69-146f-47ed-b12a-7b201fec7e502025-12-04Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.ceddc406-4a17-471f-917e-63b4b03779ea2025-10-17Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.9bc7006d-a482-47c4-a138-5380ce9278122025-10-16Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.4ad879d4-eb32-49f0-af73-c47fc75819362025-10-15Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.450ad3aa-7c9e-497b-b00e-b1af0322f8d02025-10-15Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.0151c742-7525-4707-af03-bd48d50cd5862025-10-15Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.281f9c32-e28a-46ae-9e4e-c2143aaa6c6b2025-10-15Warnings, Adverse reactionsName fallback
generic name: PENICILLIN V POTASSIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.