FDA.reportPublic FDA data

Application 220012

Type
ANDA
Sponsor
PHARMOBEDIENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDETABLET;ORAL1GMNoNo

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
A220012-001COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDE1GMTABLET / ORALAB2025-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A220012-001AB

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
2026-08-18 06:07:402026-07A220012-001COLESTIPOL HYDROCHLORIDE1GMTABLET / ORALAB2025-09-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A220012-001COLESTIPOL HYDROCHLORIDE1GMTABLET / ORALAB2025-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A220012-001COLESTIPOL HYDROCHLORIDE1GMTABLET / ORALAB2025-09-1531067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220012-001COLESTIPOL HYDROCHLORIDE1GMTABLET / ORALAB2025-09-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A220012-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A220012-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A220012-001AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220012-001AB1a50c72e98297…

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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCfa6c3e11-84e9-433d-aa74-7cd34336bbed2026-05-21Adverse reactionsName fallback
brand name: COLESTIPOL HYDROCHLORIDE
generic name: COLESTIPOL HYDROCHLORIDE
Colestipol HydrochlorideCOLESTIPOL HYDROCHLORIDEAmerican Health Packaging153e9154-1804-4d73-94b7-a31a1d37c4202025-10-01Adverse reactionsName fallback
brand name: Colestipol Hydrochloride
generic name: COLESTIPOL HYDROCHLORIDE
COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEANI Pharmaceuticals, Inc.3d380b5e-e346-4a47-ac95-faa37c6f2a512025-09-12Adverse reactionsName fallback
brand name: COLESTIPOL HYDROCHLORIDE
generic name: COLESTIPOL HYDROCHLORIDE
Colestipol HydrochlorideCOLESTIPOL HYDROCHLORIDEEdenbridge Pharmaceuticals LLC.03ca5800-4211-4383-a332-be88bd9b53042025-05-27Adverse reactionsName fallback
brand name: Colestipol Hydrochloride
generic name: COLESTIPOL HYDROCHLORIDE
Colestipol HydrochlorideCOLESTIPOL HYDROCHLORIDEMylan Pharmaceuticals Inc.dae7d51e-c117-4c8a-b018-45b01ae461002025-05-13Adverse reactionsName fallback
brand name: Colestipol Hydrochloride
generic name: COLESTIPOL HYDROCHLORIDE
Colestipol HydrochlorideCOLESTIPOL HYDROCHLORIDEMylan Pharmaceuticals Inc.4e89bf6e-c78a-402e-9cb2-8d02f6047d682025-05-07Warnings, Adverse reactionsName fallback
brand name: Colestipol Hydrochloride
generic name: COLESTIPOL HYDROCHLORIDE
Colestipol HydrochlorideCOLESTIPOL HYDROCHLORIDEIngenus Pharmaceuticals, LLC3fa27483-8346-4145-81c0-5527204d7d682025-04-16Adverse reactionsName fallback
brand name: Colestipol Hydrochloride
generic name: COLESTIPOL HYDROCHLORIDE
Colestipol hydrochlorideCOLESTIPOL HYDROCHLORIDEZydus Lifesciences Limited3b451f0b-5bd9-419a-afa2-a02eb0bbc45e2024-11-26Name fallback
brand name: Colestipol hydrochloride
generic name: COLESTIPOL HYDROCHLORIDE
ColestidCOLESTIPOL HYDROCHLORIDEPharmacia & Upjohn Company LLC3e270911-f27b-44d4-b0a2-33506418cc1d2024-10-24Adverse reactionsName fallback
generic name: COLESTIPOL HYDROCHLORIDE
ColestidCOLESTIPOL HYDROCHLORIDEPharmacia & Upjohn Company LLC21b37725-fc0c-4365-a7dc-1a473d42502d2024-06-27Warnings, Adverse reactionsName fallback
generic name: COLESTIPOL HYDROCHLORIDE
Colestipol hydrochlorideCOLESTIPOL HYDROCHLORIDEZydus Pharmaceuticals USA Inc.71f12e0d-373a-4867-b37c-f24d99c5ce952024-02-19Adverse reactionsName fallback
brand name: Colestipol hydrochloride
generic name: COLESTIPOL HYDROCHLORIDE
COLESTIPOL HYDROCHLORIDECOLESTIPOL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC839354bd-cbac-4d18-8c02-b1b93766af382023-12-30Warnings, Adverse reactionsName fallback
brand name: COLESTIPOL HYDROCHLORIDE
generic name: COLESTIPOL HYDROCHLORIDE