FDA.reportPublic FDA data

Application 211780

Type
ANDA
Sponsor
PADAGIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUCRALFATESUCRALFATESUSPENSION;ORAL1GM/10MLNoNo

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
A211780-001SUCRALFATESUCRALFATE1GM/10MLSUSPENSION / ORALAB2025-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211780-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211780-001SUCRALFATE1GM/10MLSUSPENSION / ORALAB2025-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211780-001SUCRALFATE1GM/10MLSUSPENSION / ORALAB2025-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211780-001SUCRALFATE1GM/10MLSUSPENSION / ORALAB2025-04-146a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211780-001SUCRALFATE1GM/10MLSUSPENSION / ORALAB2025-04-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211780-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211780-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211780-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211780-001AB1a50c72e98297…

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 4 · 69 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SucralfateSUCRALFATESafecor Health, LLC526f6ebc-557c-4c53-8118-1907baa0820a2026-07-16Warnings, Adverse reactionsName fallback
brand name: Sucralfate
generic name: SUCRALFATE
SucralfateSUCRALFATECardinal Health 107, LLC1eb38f64-4d5a-46e6-a030-057beece5e442026-07-10Adverse reactionsName fallback
brand name: Sucralfate
generic name: SUCRALFATE
SucralfateSUCRALFATEChartwell RX, LLC30c0965a-02a0-46b5-aa09-3f5fb5047b222026-07-06Adverse reactionsName fallback
brand name: Sucralfate
generic name: SUCRALFATE
SucralfateSUCRALFATENCS HealthCare of KY, LLC dba Vangard Labs3b0259fa-806f-44c1-8deb-c11dbd84582d2026-06-24Adverse reactionsName fallback
brand name: Sucralfate
generic name: SUCRALFATE
SucralfateSUCRALFATEASCLEMED USA INC.cd25eb96-29ea-48b2-bdee-c2ea98f216b82026-05-18Adverse reactionsName fallback
brand name: Sucralfate
generic name: SUCRALFATE
SucralfateSUCRALFATESafecor Health LLC1a6d96f2-fe1f-4aaf-8520-616973c224aa2026-04-07Adverse reactionsName fallback
brand name: Sucralfate
generic name: SUCRALFATE
SucralfateSUCRALFATECardinal Health 107, LLC92c8672a-c6b8-4ec8-a815-c30bdd960ac72026-03-30Warnings, Adverse reactionsName fallback
brand name: Sucralfate
generic name: SUCRALFATE
SucralfateSUCRALFATEPAI Holdings, LLC dba PAI Pharma113a068a-2ce9-421c-8b89-87ce30e192252026-03-11Warnings, Adverse reactionsName fallback
brand name: Sucralfate
generic name: SUCRALFATE
sucralfateSUCRALFATEStrides Pharma Science Limited8e25bff2-769e-4bd4-a6de-895c58b840d22026-03-10Warnings, Adverse reactionsName fallback
brand name: sucralfate
generic name: SUCRALFATE
SucralfateSUCRALFATE ORAL SUSPENSIONMajor Pharmaceuticals98a8fedd-fa06-416a-8a85-b899631978f92026-02-11Warnings, Adverse reactionsName fallback
brand name: Sucralfate
SucralfateSUCRALFATEPreferred Pharmaceuticals Inca434bf8f-cc60-4d84-a9a4-61c3ff6b700e2026-01-21Adverse reactionsName fallback
brand name: Sucralfate
generic name: SUCRALFATE
SucralfateSUCRALFATEAvKARE0909acc5-c746-17fb-e063-6394a90a677f2026-01-19Adverse reactionsName fallback
brand name: Sucralfate
generic name: SUCRALFATE
Sucralfate oral suspensionSUCRALFATEGlenmark Pharmaceuticals Inc., USA1e595c2a-edd0-43f7-a2db-69553b9557d92026-01-06Warnings, Adverse reactionsName fallback
generic name: SUCRALFATE
SucralfateSUCRALFATENorthwind Health Company, LLCf3095db3-fd02-873c-e053-2a95a90a5b1f2026-01-01Adverse reactionsName fallback
brand name: Sucralfate
generic name: SUCRALFATE
SucralfateSUCRALFATE ORALCardinal Health 107, LLCa0c9f585-1007-4996-aef7-e17cd55d28cd2025-12-31Warnings, Adverse reactionsName fallback
brand name: Sucralfate
SucralfateSUCRALFATE ORALTruPharma, LLC7d441128-45d2-4bf2-817b-665784992e902025-12-29Warnings, Adverse reactionsName fallback
brand name: Sucralfate
SucralfateSUCRALFATENorthwind Health Company, LLC464bf611-4dbb-4707-b9dd-39ca178ed4bf2025-12-26Adverse reactionsName fallback
brand name: Sucralfate
generic name: SUCRALFATE
SucralfateSUCRALFATERedpharm Drug3251e156-4c52-63b3-e063-6294a90a9a952025-12-18Adverse reactionsName fallback
brand name: Sucralfate
generic name: SUCRALFATE
SucralfateSUCRALFATE ORALAvKAREc019bf24-8273-8d2f-e053-2a95a90aec982025-12-03Warnings, Adverse reactionsName fallback
brand name: Sucralfate
SucralfateSUCRALFATE ORALAvPAKe78ef7d4-faa7-aebf-e053-2995a90a6f842025-12-03Warnings, Adverse reactionsName fallback
brand name: Sucralfate