Application 016640

Type: NDA
Sponsor: BRISTOL MYERS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUESTRAN	CHOLESTYRAMINE	POWDER;ORAL	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	QUESTRAN	CHOLESTYRAMINE	POWDER;ORAL	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N016640-001	QUESTRAN	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL		RLD, Approved before 1982
N016640-003	QUESTRAN	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL		RLD, Approved before 1982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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	POWDER / ORAL	RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016640-001	QUESTRAN	EQ 4GM RESIN/PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016640-003	QUESTRAN	EQ 4GM RESIN/SCOOPFUL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / ORAL	RLD, Approved before 1982	`3a93d1ddd44b…`

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cholestyramine	CHOLESTYRAMINE	AiPing Pharmaceutical, Inc.	214ea05f-de81-4026-9df9-4ce3820668ee	2026-08-20	Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Bryant Ranch Prepack	cc447b99-e654-42dd-8cf1-f9e7952a25cd	2026-07-16	Warnings, Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Bryant Ranch Prepack	b26a13e9-42a2-4869-a00a-672bb1ac4742	2026-07-13	Warnings, Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Bryant Ranch Prepack	2998a314-deb2-4a02-afab-7e8c868888e2	2026-07-13	Warnings, Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Par Health USA, LLC	b0c65058-22c3-4f57-9b61-9bc6fcd6e240	2026-06-15	Warnings, Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
CHOLESTYRAMINE	CHOLESTYRAMINE	EPIC PHARMA, LLC	d02eca8c-18d4-4b11-bb16-08748543b04d	2026-06-15	Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
CHOLESTYRAMINE	CHOLESTYRAMINE	Zydus Pharmaceuticals (USA) Inc.	acc48703-c15b-4275-aa75-749f1c07dcbb	2026-04-28	Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
CHOLESTYRAMINE	CHOLESTYRAMINE	Zydus Lifesciences Limited	a86715e3-741f-47c6-9682-1413f0f8ff0c	2026-04-28	Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
QUESTRAN	CHOLESTYRAMINE	Par Health USA, LLC	362ddd91-a63f-4ec6-841a-75785dd208c8	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: QUESTRAN generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Micro Labs Limited	09420793-7357-4194-8172-0b1cddb167fe	2026-03-05	Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
CHOLESTYRAMINE	CHOLESTYRAMINE	EPIC PHARMA, LLC	d931e372-2477-4554-912e-9d4d7d538ce2	2025-12-17	Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
CHOLESTYRAMINE	CHOLESTYRAMINE	EPIC PHARMA, LLC	c65e556a-3b6a-4466-a7ce-5b24103ed8ad	2025-12-17	Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
CHOLESTYRAMINE	CHOLESTYRAMINE	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	d82647da-465b-4e2e-8cf8-72d50f047b3e	2025-12-11	Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Macleods Pharmaceuticals Limited	8cbb1ed2-66cc-485d-a4b1-920f89fb6b3b	2025-12-09	Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
Prevalite	CHOLESTYRAMINE	Upsher-Smith Laboratories, LLC	dd434ef8-8af3-434c-a0a0-9a0b18459ba0	2025-12-02	Warnings, Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Ajanta Pharma USA Inc.	a0b64dfe-49bc-45d7-9281-9e9d6e296c40	2025-10-08	Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	TAGI Pharma, Inc.	06261db5-1435-4b91-8b54-71bfcfb1368c	2025-04-17	Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
Cholestyramine Light	CHOLESTYRAMINE	TAGI Pharma, Inc.	eb85a2c8-cdc3-48bb-844d-e220ae3701a0	2025-04-17	Warnings, Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Precision Dose, Inc.	8c7fc9c8-318c-42de-a736-c439047d8af8	2025-03-12	Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Macleods Pharmaceuticals Limited	c41529f1-16d2-4ca3-91eb-f809571f5ae3	2025-01-30	Warnings, Adverse reactions	Name fallback generic name: CHOLESTYRAMINE

Reported adverse events (FAERS/openFDA)#

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