FDA.reportPublic FDA data

Application 062198

Type
ANDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001E-MYCIN EERYTHROMYCIN ETHYLSUCCINATESUSPENSION;ORALEQ 200MG BASE/5MLNoNo
002E-MYCIN EERYTHROMYCIN ETHYLSUCCINATESUSPENSION;ORALEQ 400MG 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
A062198-001E-MYCIN EERYTHROMYCIN ETHYLSUCCINATEEQ 200MG BASE/5MLSUSPENSION / ORALApproved before 1982
A062198-002E-MYCIN EERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASE/5MLSUSPENSION / 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 UTC2022-10A062198-001E-MYCIN EEQ 200MG BASE/5MLSUSPENSION / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A062198-002E-MYCIN EEQ 400MG BASE/5MLSUSPENSION / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062198-001E-MYCIN EEQ 200MG BASE/5MLSUSPENSION / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A062198-002E-MYCIN EEQ 400MG BASE/5MLSUSPENSION / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062198-001E-MYCIN EEQ 200MG BASE/5MLSUSPENSION / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062198-002E-MYCIN EEQ 400MG BASE/5MLSUSPENSION / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A062198-001E-MYCIN EEQ 200MG BASE/5MLSUSPENSION / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A062198-002E-MYCIN EEQ 400MG BASE/5MLSUSPENSION / 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 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
E.E.S 400ERYTHROMYCIN ETHYLSUCCINATEREMEDYREPACK INC.49b3ca93-43cc-439c-8f5d-e3ea2e87ad2f2026-06-23Warnings, Adverse reactionsName fallback
generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin ethylsuccinateERYTHROMYCIN ETHYLSUCCINATEBryant Ranch Prepack78139f33-0965-4bbb-a53f-6d7fd4fa9a812026-06-05Warnings, Adverse reactionsName fallback
generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin ethylsuccinateERYTHROMYCIN ETHYLSUCCINATEBryant Ranch Prepack1d9eb7cb-0b11-4f6e-8a9c-1bcff37fe0b52026-06-05Warnings, Adverse reactionsName fallback
generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin ethylsuccinateERYTHROMYCIN ETHYLSUCCINATEKanchan Healthcare Inca7f7faaf-dc05-4d51-86c6-bf5d61562e482026-04-08Warnings, Adverse reactionsName fallback
generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin EthylsuccinateERYTHROMYCIN ETHYLSUCCINATEANI Pharmaceuticals, Inc.3d80f96e-3bbe-4fa5-89a8-694c61dd5e8f2025-06-20Warnings, Adverse reactionsName fallback
generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin EthylsuccinateERYTHROMYCIN ETHYLSUCCINATEANI Pharmaceuticals, Inc.3de1e0b9-473b-44c0-a644-5fa14ad69a832025-06-20Warnings, Adverse reactionsName fallback
generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin EthylsuccinateERYTHROMYCIN ETHYLSUCCINATENivagen Pharmaceuticals, Inc.46f74c4f-10fc-44cf-aec4-d113f49149bc2024-01-02Warnings, Adverse reactionsName fallback
generic name: ERYTHROMYCIN ETHYLSUCCINATE
E.E.S 400ERYTHROMYCIN ETHYLSUCCINATEAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)b455bbdb-a3f1-470f-aa5f-ed83ac2e228d2023-12-16Warnings, Adverse reactionsName fallback
generic name: ERYTHROMYCIN ETHYLSUCCINATE
Ery-PedERYTHROMYCIN ETHYLSUCCINATEAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)04775721-ab87-4b66-808c-d67a210323852023-12-16Warnings, Adverse reactionsName fallback
generic name: ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROMYCIN ETHYLSUCCINATEERYTHROMYCIN ETHYLSUCCINATEAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)23a0564e-dca9-41bc-b2c7-0461169f65f92023-12-16Warnings, Adverse reactionsName fallback
generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin ethylsuccinateERYTHROMYCIN ETHYLSUCCINATECadila Pharmaceuticals Limiteddb70798e-5e07-41d6-afe9-82c272bc5cc02023-11-11Warnings, Adverse reactionsName fallback
generic name: ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROMYCIN ETHYLSUCCINATEERYTHROMYCIN ETHYLSUCCINATEWilshire Pharmaceuticals86d6353c-2b58-4219-b31d-fb5b977890942020-09-24Warnings, Adverse reactionsName fallback
generic name: ERYTHROMYCIN ETHYLSUCCINATE
Erythromycin EthylsuccinateERYTHROMYCIN ETHYLSUCCINATEWilshire Pharmaceuticals Inc.f4a3fffd-ce02-450f-bbcc-d425374e3e322019-01-29Warnings, Adverse reactionsName fallback
generic name: ERYTHROMYCIN ETHYLSUCCINATE

Reported adverse events (FAERS/openFDA)#

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