Application 061996

Type: ANDA
Sponsor: CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FULVICIN P/G	GRISEOFULVIN, ULTRAMICROCRYSTALLINE	TABLET;ORAL	125MG	No	No
002	FULVICIN P/G	GRISEOFULVIN, ULTRAMICROCRYSTALLINE	TABLET;ORAL	250MG	No	No
003	FULVICIN P/G 165	GRISEOFULVIN, ULTRAMICROCRYSTALLINE	TABLET;ORAL	165MG	No	No
004	FULVICIN P/G 330	GRISEOFULVIN, ULTRAMICROCRYSTALLINE	TABLET;ORAL	330MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A061996-001	FULVICIN P/G	GRISEOFULVIN, ULTRAMICROSIZE	125MG	TABLET / ORAL	AB	Approved before 1982
A061996-002	FULVICIN P/G	GRISEOFULVIN, ULTRAMICROSIZE	250MG	TABLET / ORAL	AB	Approved before 1982
A061996-003	FULVICIN P/G 165	GRISEOFULVIN, ULTRAMICROSIZE	165MG	TABLET / ORAL			1982-04-06
A061996-004	FULVICIN P/G 330	GRISEOFULVIN, ULTRAMICROSIZE	330MG	TABLET / ORAL			1982-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A061996-001	AB
A061996-002	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 5 · 176 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
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061996-001	FULVICIN P/G	125MG	TABLET / ORAL	AB	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061996-002	FULVICIN P/G	250MG	TABLET / ORAL	AB	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061996-003	FULVICIN P/G 165	165MG	TABLET / ORAL			1982-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061996-004	FULVICIN P/G 330	330MG	TABLET / ORAL			1982-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061996-001	FULVICIN P/G	125MG	TABLET / ORAL	AB	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061996-002	FULVICIN P/G	250MG	TABLET / ORAL	AB	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061996-003	FULVICIN P/G 165	165MG	TABLET / ORAL			1982-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061996-004	FULVICIN P/G 330	330MG	TABLET / ORAL			1982-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061996-001	FULVICIN P/G	125MG	TABLET / ORAL	AB	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061996-002	FULVICIN P/G	250MG	TABLET / ORAL	AB	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061996-003	FULVICIN P/G 165	165MG	TABLET / ORAL			1982-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061996-004	FULVICIN P/G 330	330MG	TABLET / ORAL			1982-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061996-001	FULVICIN P/G	125MG	TABLET / ORAL	AB	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061996-002	FULVICIN P/G	250MG	TABLET / ORAL	AB	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061996-003	FULVICIN P/G 165	165MG	TABLET / ORAL			1982-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061996-004	FULVICIN P/G 330	330MG	TABLET / ORAL			1982-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061996-001	FULVICIN P/G	125MG	TABLET / ORAL	AB	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061996-002	FULVICIN P/G	250MG	TABLET / ORAL	AB	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061996-003	FULVICIN P/G 165	165MG	TABLET / ORAL			1982-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061996-004	FULVICIN P/G 330	330MG	TABLET / ORAL			1982-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061996-001	FULVICIN P/G	125MG	TABLET / ORAL	AB	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061996-002	FULVICIN P/G	250MG	TABLET / ORAL	AB	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061996-003	FULVICIN P/G 165	165MG	TABLET / ORAL			1982-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061996-004	FULVICIN P/G 330	330MG	TABLET / ORAL			1982-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061996-001	FULVICIN P/G	125MG	TABLET / ORAL	AB	Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A061996-002	FULVICIN P/G	250MG	TABLET / ORAL	AB	Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A061996-003	FULVICIN P/G 165	165MG	TABLET / ORAL			1982-04-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A061996-004	FULVICIN P/G 330	330MG	TABLET / ORAL			1982-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061996-001	FULVICIN P/G	125MG	TABLET / ORAL	AB	Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061996-002	FULVICIN P/G	250MG	TABLET / ORAL	AB	Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061996-003	FULVICIN P/G 165	165MG	TABLET / ORAL	AB		1982-04-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061996-004	FULVICIN P/G 330	330MG	TABLET / ORAL	AB		1982-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061996-001	FULVICIN P/G	125MG	TABLET / ORAL	AB	Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A061996-002	FULVICIN P/G	250MG	TABLET / ORAL	AB	Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A061996-003	FULVICIN P/G 165	165MG	TABLET / ORAL	AB		1982-04-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A061996-004	FULVICIN P/G 330	330MG	TABLET / ORAL	AB		1982-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061996-001	FULVICIN P/G	125MG	TABLET / ORAL	AB	Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A061996-002	FULVICIN P/G	250MG	TABLET / ORAL	AB	Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A061996-003	FULVICIN P/G 165	165MG	TABLET / ORAL	AB		1982-04-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A061996-004	FULVICIN P/G 330	330MG	TABLET / ORAL	AB		1982-04-06	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	A061996-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A061996-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A061996-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A061996-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A061996-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061996-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061996-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061996-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061996-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061996-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061996-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061996-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061996-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061996-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061996-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061996-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061996-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061996-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061996-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061996-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061996-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061996-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061996-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061996-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061996-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061996-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061996-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061996-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061996-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061996-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061996-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061996-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061996-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A061996-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061996-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061996-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061996-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061996-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061996-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A061996-002	AB	1	`5d02ea3f76ae…`

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
Ultramicrosize Griseofulvin	GRISEOFULVIN	Chartwell RX, LLC.	efb8a660-802c-4ca6-bbff-ad7b48b91aef	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061996 application number: ANDA061996 ndc (product): 62135-495 ndc (product): 62135-494
Ultramicrosize Griseofulvin	GRISEOFULVIN	Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	ae369582-2e4c-48a4-ac42-0a77466654fd	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061996 application number: ANDA061996
ULTRAMICROSIZE GRISEOFULVIN	ULTRAMICROSIZE GRISEOFULVIN	Chartwell RX, LLC	640c489e-f491-4805-a390-ef4be43e261b	2025-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061996 application number: ANDA061996
ULTRAMICROSIZE GRISEOFULVIN	ULTRAMICROSIZE GRISEOFULVIN	Ayurax, LLC.	43fc5201-d23c-4d83-9247-baefe03774ef	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061996 application number: ANDA061996

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62135-494	Ultramicrosize Griseofulvin	Griseofulvin	Chartwell RX, LLC.	ANDA	Current
62135-494	Ultramicrosize Griseofulvin	Griseofulvin	Chartwell RX, LLC.	ANDA	Current
62135-495	Ultramicrosize Griseofulvin	Griseofulvin	Chartwell RX, LLC.	ANDA	Current
62135-495	Ultramicrosize Griseofulvin	Griseofulvin	Chartwell RX, LLC.	ANDA	Current