Application 060569

Type: ANDA
Sponsor: CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FULVICIN-U/F	GRISEOFULVIN, MICROCRYSTALLINE	TABLET;ORAL	500MG	No	No
002	FULVICIN-U/F	GRISEOFULVIN, MICROCRYSTALLINE	TABLET;ORAL	250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A060569-001	FULVICIN-U/F	GRISEOFULVIN, MICROSIZE	500MG	TABLET / ORAL	AB	Approved before 1982
A060569-002	FULVICIN-U/F	GRISEOFULVIN, MICROSIZE	250MG	TABLET / ORAL	AB	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
A060569-001	AB
A060569-002	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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL		Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL		Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL		Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL		Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL		Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL		Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL		Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL		Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL		Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL		Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL		Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL		Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL		Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL		Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL		Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL		Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL		Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL		Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL		Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL		Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL		Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL		Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL		Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL		Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL		Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL		Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL		Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL		Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL		Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL		Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A060569-001	FULVICIN-U/F	500MG	TABLET / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A060569-002	FULVICIN-U/F	250MG	TABLET / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A060569-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A060569-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A060569-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A060569-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A060569-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A060569-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A060569-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060569-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060569-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060569-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A060569-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060569-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060569-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060569-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060569-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060569-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A060569-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A060569-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A060569-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A060569-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A060569-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A060569-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A060569-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A060569-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A060569-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A060569-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060569-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060569-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060569-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060569-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060569-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060569-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A060569-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A060569-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060569-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060569-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A060569-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A060569-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A060569-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A060569-002	AB	1	`4b0b4de00fa7…`

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
GRISEOFULVIN MICROSIZE	GRISEOFULVIN	Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	1c26d7a6-17d9-4a95-a4ee-cfc5fe6bb95d	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060569 application number: ANDA060569
Griseofulvin MICROSIZE	GRISEOFULVIN	Chartwell RX, LLC.	6902a976-b0c5-48a4-8d50-984002be6c3a	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060569 application number: ANDA060569 ndc (product): 62135-496

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62135-496	Griseofulvin MICROSIZE	griseofulvin	Chartwell RX, LLC.	ANDA	Current
62135-496	Griseofulvin MICROSIZE	griseofulvin	Chartwell RX, LLC.	ANDA	Current