Application 074558

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE	POWDER;ORAL	EQ 4GM RESIN/PACKET	No	Yes
002	CHOLESTYRAMINE LIGHT	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
A074558-001	CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15
A074558-002	CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074558-001	AB
A074558-002	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074558-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074558-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074558-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074558-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074558-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074558-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074558-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074558-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074558-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074558-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074558-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074558-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074558-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074558-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074558-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074558-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074558-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074558-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074558-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074558-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074558-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074558-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074558-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074558-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074558-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074558-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074558-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074558-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074558-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074558-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074558-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074558-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074558-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074558-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074558-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074558-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074558-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074558-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074558-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074558-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074558-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074558-002	AB	1	`bb7c543d1eb4…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE LIGHT	EPIC PHARMA, LLC	00990dec-7618-4cc8-9387-48c2cea8df1c	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074558 application number: ANDA074558 ndc (product): 42806-269
CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE LIGHT	EPIC PHARMA, LLC	3899f0e0-988b-45dc-8ebd-a04330e75ee3	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074558 application number: ANDA074558 ndc (product): 42806-270
CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE LIGHT	EPIC PHARMA, LLC	f8740b85-75f9-4e00-a8d3-7175298f1724	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074558 application number: ANDA074558 ndc (product): 42806-271
CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE LIGHT	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	31655681-125c-4eaa-959b-8f434bb43590	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074558 application number: ANDA074558

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0939	cholestyramine light	cholestyramine light	Eon Labs, Inc.	ANDA	Current
0185-0939	cholestyramine light	cholestyramine light	Eon Labs, Inc.	ANDA	Current
0185-0939	cholestyramine light	cholestyramine light	Eon Labs, Inc.	ANDA	Current
42806-269	CHOLESTYRAMINE LIGHT	cholestyramine light	EPIC PHARMA, LLC	ANDA	Current
42806-270	CHOLESTYRAMINE LIGHT	cholestyramine light	EPIC PHARMA, LLC	ANDA	Current
42806-271	CHOLESTYRAMINE LIGHT	cholestyramine light	EPIC PHARMA, LLC	ANDA	Current