FDA.reportPublic FDA data

Application 062153

Type
ANDA
Sponsor
APOTHECON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VEETIDS '125'PENICILLIN V POTASSIUMFOR SOLUTION;ORALEQ 125MG BASE/5MLNoNo
002VEETIDS '250'PENICILLIN 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
A062153-001VEETIDS '125'PENICILLIN V POTASSIUMEQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982
A062153-002VEETIDS '250'PENICILLIN 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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A062153-001VEETIDS '125'EQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A062153-002VEETIDS '250'EQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062153-001VEETIDS '125'EQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A062153-002VEETIDS '250'EQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062153-001VEETIDS '125'EQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062153-002VEETIDS '250'EQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A062153-001VEETIDS '125'EQ 125MG BASE/5MLFOR SOLUTION / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A062153-002VEETIDS '250'EQ 250MG BASE/5MLFOR SOLUTION / ORALApproved before 1982a50c72e98297…

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.