Application 214877

Type: ANDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHOLESTYRAMINE	CHOLESTYRAMINE	POWDER;ORAL	EQ 4GM RESIN/PACKET	No	No
002	CHOLESTYRAMINE	CHOLESTYRAMINE	POWDER;ORAL	EQ 4GM RESIN/SCOOPFUL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A214877-001	CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB		2022-01-21
A214877-002	CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		2022-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A214877-001	AB
A214877-002	AB

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 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2022-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2022-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2022-01-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2022-01-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2022-01-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2022-01-21	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214877-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL		2022-01-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214877-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL		2022-01-21	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214877-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214877-002	AB	1	`caaa826d4ba7…`
2022-04-04 05:41 UTC	2022-04	A214877-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214877-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214877-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214877-002	AB	1	`bb7c543d1eb4…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214877-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214877-002	AB	1	`a50c72e98297…`

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 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cholestyramine	CHOLESTYRAMINE	Bryant Ranch Prepack	cc447b99-e654-42dd-8cf1-f9e7952a25cd	2026-07-16	Warnings, Adverse reactions	Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Bryant Ranch Prepack	b26a13e9-42a2-4869-a00a-672bb1ac4742	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Bryant Ranch Prepack	2998a314-deb2-4a02-afab-7e8c868888e2	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Par Health USA, LLC	b0c65058-22c3-4f57-9b61-9bc6fcd6e240	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE
CHOLESTYRAMINE	CHOLESTYRAMINE	EPIC PHARMA, LLC	d02eca8c-18d4-4b11-bb16-08748543b04d	2026-06-15	Adverse reactions	Name fallback brand name: CHOLESTYRAMINE generic name: CHOLESTYRAMINE
CHOLESTYRAMINE	CHOLESTYRAMINE	Zydus Pharmaceuticals (USA) Inc.	acc48703-c15b-4275-aa75-749f1c07dcbb	2026-04-28	Adverse reactions	Name fallback brand name: CHOLESTYRAMINE generic name: CHOLESTYRAMINE
CHOLESTYRAMINE	CHOLESTYRAMINE	Zydus Lifesciences Limited	a86715e3-741f-47c6-9682-1413f0f8ff0c	2026-04-28	Adverse reactions	Name fallback brand name: CHOLESTYRAMINE generic name: CHOLESTYRAMINE
QUESTRAN	CHOLESTYRAMINE	Par Health USA, LLC	362ddd91-a63f-4ec6-841a-75785dd208c8	2026-04-17	Warnings, Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Micro Labs Limited	09420793-7357-4194-8172-0b1cddb167fe	2026-03-05	Adverse reactions	Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE
CHOLESTYRAMINE	CHOLESTYRAMINE	EPIC PHARMA, LLC	d931e372-2477-4554-912e-9d4d7d538ce2	2025-12-17	Adverse reactions	Name fallback brand name: CHOLESTYRAMINE generic name: CHOLESTYRAMINE
CHOLESTYRAMINE	CHOLESTYRAMINE	EPIC PHARMA, LLC	c65e556a-3b6a-4466-a7ce-5b24103ed8ad	2025-12-17	Adverse reactions	Name fallback brand name: CHOLESTYRAMINE generic name: CHOLESTYRAMINE
CHOLESTYRAMINE	CHOLESTYRAMINE	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	d82647da-465b-4e2e-8cf8-72d50f047b3e	2025-12-11	Adverse reactions	Name fallback brand name: CHOLESTYRAMINE generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Macleods Pharmaceuticals Limited	8cbb1ed2-66cc-485d-a4b1-920f89fb6b3b	2025-12-09	Adverse reactions	Name fallback brand name: Cholestyramine 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 brand name: Cholestyramine generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	TAGI Pharma, Inc.	06261db5-1435-4b91-8b54-71bfcfb1368c	2025-04-17	Adverse reactions	Name fallback brand name: Cholestyramine 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 brand name: Cholestyramine generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Macleods Pharmaceuticals Limited	c41529f1-16d2-4ca3-91eb-f809571f5ae3	2025-01-30	Warnings, Adverse reactions	Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Bryant Ranch Prepack	c58d6bd9-0273-4c16-8533-495170413d8c	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: Cholestyramine generic name: CHOLESTYRAMINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0832-0536	Cholestyramine	Cholestyramine	Upsher-Smith Laboratories,LLC	ANDA	Current