Application 074557

Type: ANDA
Sponsor: SANDOZ

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	Yes
002	CHOLESTYRAMINE	CHOLESTYRAMINE	POWDER;ORAL	EQ 4GM RESIN/SCOOPFUL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A074557-001	CHOLESTYRAMINE	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15
A074557-002	CHOLESTYRAMINE	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
A074557-001	AB
A074557-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074557-001	CHOLESTYRAMINE	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	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074557-001	CHOLESTYRAMINE	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	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074557-001	CHOLESTYRAMINE	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	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074557-001	CHOLESTYRAMINE	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	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074557-001	CHOLESTYRAMINE	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	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074557-001	CHOLESTYRAMINE	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	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074557-001	CHOLESTYRAMINE	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	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074557-001	CHOLESTYRAMINE	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	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074557-001	CHOLESTYRAMINE	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	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074557-001	CHOLESTYRAMINE	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	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074557-001	CHOLESTYRAMINE	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	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074557-001	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	RS	1996-08-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074557-002	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		1996-08-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074557-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074557-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074557-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074557-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074557-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074557-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074557-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074557-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074557-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074557-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074557-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074557-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074557-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074557-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074557-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074557-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074557-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074557-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074557-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074557-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074557-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074557-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074557-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074557-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074557-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074557-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074557-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074557-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074557-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074557-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074557-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074557-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074557-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074557-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074557-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074557-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074557-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074557-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074557-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074557-002	AB	1	`782e0a99824c…`

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	CHOLESTYRAMINE	EPIC PHARMA, LLC	d02eca8c-18d4-4b11-bb16-08748543b04d	2026-06-15	Adverse reactions	Exact identifier application applno (ANDA): 074557 application number: ANDA074557 ndc (product): 42806-265
CHOLESTYRAMINE	CHOLESTYRAMINE	EPIC PHARMA, LLC	d931e372-2477-4554-912e-9d4d7d538ce2	2025-12-17	Adverse reactions	Exact identifier application applno (ANDA): 074557 application number: ANDA074557 ndc (product): 42806-266
CHOLESTYRAMINE	CHOLESTYRAMINE	EPIC PHARMA, LLC	c65e556a-3b6a-4466-a7ce-5b24103ed8ad	2025-12-17	Adverse reactions	Exact identifier application applno (ANDA): 074557 application number: ANDA074557 ndc (product): 42806-267
CHOLESTYRAMINE	CHOLESTYRAMINE	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	d82647da-465b-4e2e-8cf8-72d50f047b3e	2025-12-11	Adverse reactions	Exact identifier application applno (ANDA): 074557 application number: ANDA074557

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0185-0940	Cholestyramine	Cholestyramine	Eon Labs, Inc.	ANDA	Current
0185-0940	Cholestyramine	Cholestyramine	Eon Labs, Inc.	ANDA	Current
0185-0940	Cholestyramine	Cholestyramine	Eon Labs, Inc.	ANDA	Current
0245-0536	Cholestyramine	Cholestyramine	Upsher-Smith Laboratories, Inc.	ANDA	Current
0245-0536	Cholestyramine	Cholestyramine	Upsher-Smith Laboratories, Inc.	ANDA	Current
0245-0536	Cholestyramine	Cholestyramine	Upsher-Smith Laboratories, Inc.	ANDA	Current
42806-265	CHOLESTYRAMINE	cholestyramine	EPIC PHARMA, LLC	ANDA	Current
42806-266	CHOLESTYRAMINE	cholestyramine	EPIC PHARMA, LLC	ANDA	Current
42806-267	CHOLESTYRAMINE	cholestyramine	EPIC PHARMA, LLC	ANDA	Current