Application 077203

Type: ANDA
Sponsor: PAR PHARM

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	No
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
A077203-001	CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB		2005-08-26
A077203-002	CHOLESTYRAMINE LIGHT	CHOLESTYRAMINE	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB		2005-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077203-001	AB
A077203-002	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077203-001	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/PACKET	POWDER / ORAL	AB	2005-08-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077203-002	CHOLESTYRAMINE LIGHT	EQ 4GM RESIN/SCOOPFUL	POWDER / ORAL	AB	2005-08-26	`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	A077203-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077203-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077203-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077203-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077203-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077203-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077203-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077203-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077203-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077203-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077203-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077203-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077203-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077203-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077203-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077203-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077203-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077203-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077203-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077203-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077203-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077203-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077203-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077203-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077203-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077203-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077203-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077203-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077203-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077203-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077203-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077203-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077203-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077203-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077203-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077203-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077203-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077203-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077203-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077203-002	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	CHOLESTYRAMINE	Bryant Ranch Prepack	b26a13e9-42a2-4869-a00a-672bb1ac4742	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077203 application number: ANDA077203 ndc (product): 63629-2162
Cholestyramine	CHOLESTYRAMINE	Par Health USA, LLC	b0c65058-22c3-4f57-9b61-9bc6fcd6e240	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077203 application number: ANDA077203 ndc (product): 49884-466
QUESTRAN	CHOLESTYRAMINE	Endo USA, Inc.	362ddd91-a63f-4ec6-841a-75785dd208c8	2024-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077203 application number: ANDA077203 ndc (product): 49884-937
Cholestyramine	CHOLESTYRAMINE	Bryant Ranch Prepack	c58d6bd9-0273-4c16-8533-495170413d8c	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077203 application number: ANDA077203

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-466	Cholestyramine	cholestyramine	Par Pharmaceutical, Inc.	ANDA	Current
49884-466	Cholestyramine	cholestyramine	Par Pharmaceutical, Inc.	ANDA	Current
49884-466	Cholestyramine	cholestyramine	Par Pharmaceutical, Inc.	ANDA	Current
49884-937	QUESTRAN	Cholestyramine	Par Pharmaceutical, Inc.	ANDA	Current
49884-937	QUESTRAN	Cholestyramine	Par Pharmaceutical, Inc.	ANDA	Current
63629-2161	Cholestyramine	cholestyramine	Bryant Ranch Prepack	ANDA	Current
63629-2161	Cholestyramine	cholestyramine	Bryant Ranch Prepack	ANDA	Current
63629-2161	Cholestyramine	cholestyramine	Bryant Ranch Prepack	ANDA	Current
63629-2162	Cholestyramine	cholestyramine	Bryant Ranch Prepack	ANDA	Current
63629-2162	Cholestyramine	cholestyramine	Bryant Ranch Prepack	ANDA	Current
63629-2162	Cholestyramine	cholestyramine	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22599	ORIG	2012-11-14