Application 073403

Type: ANDA
Sponsor: APOTHECON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUESTRAN	CHOLESTYRAMINE	TABLET;ORAL	EQ 1GM RESIN	No	No
002	QUESTRAN	CHOLESTYRAMINE	TABLET;ORAL	EQ 800MG RESIN	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A073403-001	QUESTRAN	CHOLESTYRAMINE	EQ 1GM RESIN	TABLET / ORAL			1994-04-28
A073403-002	QUESTRAN	CHOLESTYRAMINE	EQ 800MG RESIN	TABLET / ORAL			1999-12-27

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073403-001	QUESTRAN	EQ 1GM RESIN	TABLET / ORAL	1994-04-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A073403-002	QUESTRAN	EQ 800MG RESIN	TABLET / ORAL	1999-12-27	`74a2ff9319b5…`

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cholestyramine	CHOLESTYRAMINE	Bryant Ranch Prepack	c58d6bd9-0273-4c16-8533-495170413d8c	2024-08-23	Warnings, Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
CHOLESTYRAMINE	CHOLESTYRAMINE	Zydus Lifesciences Limited	d7c6bc5e-1916-43bf-b943-98f00f41b8de	2024-01-25	Warnings, Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
CHOLESTYRAMINE	CHOLESTYRAMINE	Zydus Pharmaceuticals (USA) Inc.	2dcf7652-0c3e-4bc3-abfd-20a5b3d2a4f4	2024-01-24	Warnings, Adverse reactions	Name fallback generic name: CHOLESTYRAMINE
Cholestyramine	CHOLESTYRAMINE	Precision Dose, Inc.	129fa522-b66b-4bb1-9ac6-74f98d93a86f	2023-12-20	Warnings, Adverse reactions	Name fallback generic name: CHOLESTYRAMINE

Reported adverse events (FAERS/openFDA)#

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