Application 202545

Type: ANDA
Sponsor: SIGMAPHARM LABS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GRISEOFULVIN,ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	TABLET;ORAL	125MG	No	No
002	GRISEOFULVIN,ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	TABLET;ORAL	250MG	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
A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB		2012-10-22
A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB		2012-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202545-001	AB
A202545-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202545-001	GRISEOFULVIN,ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	2012-10-22	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202545-002	GRISEOFULVIN,ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	2012-10-22	`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	A202545-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202545-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202545-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202545-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202545-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202545-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202545-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202545-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202545-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202545-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202545-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202545-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202545-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202545-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202545-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202545-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202545-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202545-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202545-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202545-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202545-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202545-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202545-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202545-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202545-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202545-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202545-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202545-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202545-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202545-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202545-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202545-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202545-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202545-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202545-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202545-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202545-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202545-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202545-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202545-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ultramicrosize Griseofulvin	ULTRAMICROSIZE GRISEOFULVIN	Sigmapharm Laboratories, LLC	37b4d132-84f1-4394-b468-7e74eeec61eb	2022-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202545 application number: ANDA202545 ndc (product): 42794-014 ndc (product): 42794-013

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42794-013	Griseofulvin	Griseofulvin	Sigmapharm Laboratories, LLC	ANDA	Current
42794-013	Ultramicrosize Griseofulvin	Ultramicrosize Griseofulvin	Sigmapharm Laboratories, LLC	ANDA	Current
42794-014	Griseofulvin	Griseofulvin	Sigmapharm Laboratories, LLC	ANDA	Current
42794-014	Ultramicrosize Griseofulvin	Ultramicrosize Griseofulvin	Sigmapharm Laboratories, LLC	ANDA	Current
64980-184	Griseofulvin	Griseofulvin	Rising Pharmaceuticals, Inc	ANDA	Current
64980-185	Griseofulvin	Griseofulvin	Rising Pharmaceuticals, Inc	ANDA	Current