Application 020222

Type: NDA
Sponsor: PHARMACIA UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COLESTID	COLESTIPOL HYDROCHLORIDE	TABLET;ORAL	1GM	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020222-001	COLESTID	COLESTIPOL HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RLD	1994-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020222-001	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 · 42 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	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD, RS	1994-07-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD, RS	1994-07-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD, RS	1994-07-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD, RS	1994-07-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD, RS	1994-07-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD, RS	1994-07-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD, RS	1994-07-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD, RS	1994-07-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD, RS	1994-07-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD, RS	1994-07-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD, RS	1994-07-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD, RS	1994-07-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020222-001	COLESTID	1GM	TABLET / ORAL	AB	RLD	1994-07-19	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N020222-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020222-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020222-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020222-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020222-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020222-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020222-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020222-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020222-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020222-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020222-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020222-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020222-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020222-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020222-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020222-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020222-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020222-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020222-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020222-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020222-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020222-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020222-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020222-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020222-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020222-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020222-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020222-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020222-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020222-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020222-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020222-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020222-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020222-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020222-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020222-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020222-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020222-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020222-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020222-001	AB	1	`e64feba35796…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colestipol Hydrochloride	COLESTIPOL HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	dae7d51e-c117-4c8a-b018-45b01ae46100	2025-05-13	Adverse reactions	Exact identifier application applno (NDA): 020222 application number: NDA020222 ndc (product): 59762-0450
Colestid	COLESTIPOL HYDROCHLORIDE	Pharmacia & Upjohn Company LLC	3e270911-f27b-44d4-b0a2-33506418cc1d	2024-10-24	Adverse reactions	Exact identifier application applno (NDA): 020222 application number: NDA020222 ndc (product): 0009-0450

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0009-0450	Colestid	Colestipol Hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0450	Colestid	Colestipol Hydrochloride	Pharmacia and Upjohn Company LLC	NDA	Current
0009-0450	Colestid	Colestipol Hydrochloride	Pharmacia & Upjohn Company LLC	NDA	Current
59762-0450	Colestipol Hydrochloride	Colestipol Hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0450	Colestipol Hydrochloride	Colestipol Hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0450	Colestipol Hydrochloride	Colestipol Hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
68151-4361	Colestipol Hydrochloride	Colestipol Hydrochloride	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48550	SUPPL	2017-05-26
48534	SUPPL	2017-05-25
12330	SUPPL	2014-05-28
24598	SUPPL	2014-05-23