Application 050475

Type: NDA
Sponsor: VALEANT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GRIS-PEG	GRISEOFULVIN, ULTRAMICROSIZE	TABLET;ORAL	125MG	Yes	No
002	GRIS-PEG	GRISEOFULVIN, ULTRAMICROSIZE	TABLET;ORAL	250MG	Yes	Yes

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
N050475-001	GRIS-PEG	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	RLD, Approved before 1982
N050475-002	GRIS-PEG	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050475-001	AB
N050475-002	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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050475-001	GRIS-PEG	125MG	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050475-002	GRIS-PEG	250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	N050475-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050475-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050475-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050475-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050475-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050475-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050475-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050475-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050475-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050475-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050475-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050475-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050475-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050475-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050475-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050475-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050475-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050475-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050475-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050475-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050475-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050475-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050475-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050475-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050475-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050475-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050475-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050475-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050475-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050475-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050475-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050475-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050475-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050475-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050475-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050475-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050475-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050475-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050475-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050475-002	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0884-0763	Gris-PEG	griseofulvin	Pedinol Pharmacal, Inc.	NDA	Current
0884-0773	Gris-PEG	griseofulvin	Pedinol Pharmacal, Inc.	NDA	Current
53808-0261	Gris-PEG	GRISEOFULVIN	State of Florida DOH Central Pharmacy	NDA	Current
68682-519	Griseofulvin	Griseofulvin	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-520	Griseofulvin	Griseofulvin	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83957	SUPPL	2025-10-28
83956	SUPPL	2025-10-28
7764	SUPPL	2016-04-22
17843	SUPPL	2016-04-20
30043	SUPPL	2010-10-25
17842	SUPPL	2010-10-19
38949	SUPPL	2007-02-02
7763	SUPPL	2007-02-02
30042	SUPPL	2003-04-14
17841	SUPPL	2003-03-28