Application 077246

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DANAZOL	DANAZOL	CAPSULE;ORAL	200MG	No	No
002	DANAZOL	DANAZOL	CAPSULE;ORAL	50MG	No	No
003	DANAZOL	DANAZOL	CAPSULE;ORAL	100MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077246-001	DANAZOL	DANAZOL	200MG	CAPSULE / ORAL	AB	2005-09-28
A077246-002	DANAZOL	DANAZOL	50MG	CAPSULE / ORAL	AB	2007-04-19
A077246-003	DANAZOL	DANAZOL	100MG	CAPSULE / ORAL	AB	2007-04-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077246-001	AB
A077246-002	AB
A077246-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A077246-001	DANAZOL	200MG	CAPSULE / ORAL	AB	2005-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077246-002	DANAZOL	50MG	CAPSULE / ORAL	AB	2007-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077246-003	DANAZOL	100MG	CAPSULE / ORAL	AB	2007-04-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077246-001	DANAZOL	200MG	CAPSULE / ORAL	AB	2005-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077246-002	DANAZOL	50MG	CAPSULE / ORAL	AB	2007-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077246-003	DANAZOL	100MG	CAPSULE / ORAL	AB	2007-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077246-001	DANAZOL	200MG	CAPSULE / ORAL	AB	2005-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077246-002	DANAZOL	50MG	CAPSULE / ORAL	AB	2007-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077246-003	DANAZOL	100MG	CAPSULE / ORAL	AB	2007-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077246-001	DANAZOL	200MG	CAPSULE / ORAL	AB	2005-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077246-002	DANAZOL	50MG	CAPSULE / ORAL	AB	2007-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077246-003	DANAZOL	100MG	CAPSULE / ORAL	AB	2007-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077246-001	DANAZOL	200MG	CAPSULE / ORAL	AB	2005-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077246-002	DANAZOL	50MG	CAPSULE / ORAL	AB	2007-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077246-003	DANAZOL	100MG	CAPSULE / ORAL	AB	2007-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077246-001	DANAZOL	200MG	CAPSULE / ORAL	AB	2005-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077246-002	DANAZOL	50MG	CAPSULE / ORAL	AB	2007-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077246-003	DANAZOL	100MG	CAPSULE / ORAL	AB	2007-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077246-001	DANAZOL	200MG	CAPSULE / ORAL	AB	2005-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077246-002	DANAZOL	50MG	CAPSULE / ORAL	AB	2007-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077246-003	DANAZOL	100MG	CAPSULE / ORAL	AB	2007-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077246-001	DANAZOL	200MG	CAPSULE / ORAL	AB	2005-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077246-002	DANAZOL	50MG	CAPSULE / ORAL	AB	2007-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077246-003	DANAZOL	100MG	CAPSULE / ORAL	AB	2007-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077246-001	DANAZOL	200MG	CAPSULE / ORAL	AB	2005-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077246-002	DANAZOL	50MG	CAPSULE / ORAL	AB	2007-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077246-003	DANAZOL	100MG	CAPSULE / ORAL	AB	2007-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077246-001	DANAZOL	200MG	CAPSULE / ORAL	AB	2005-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077246-002	DANAZOL	50MG	CAPSULE / ORAL	AB	2007-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077246-003	DANAZOL	100MG	CAPSULE / ORAL	AB	2007-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077246-001	DANAZOL	200MG	CAPSULE / ORAL	AB	2005-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077246-002	DANAZOL	50MG	CAPSULE / ORAL	AB	2007-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077246-003	DANAZOL	100MG	CAPSULE / ORAL	AB	2007-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077246-001	DANAZOL	200MG	CAPSULE / ORAL	AB	2005-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077246-002	DANAZOL	50MG	CAPSULE / ORAL	AB	2007-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077246-003	DANAZOL	100MG	CAPSULE / ORAL	AB	2007-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077246-001	DANAZOL	200MG	CAPSULE / ORAL	AB	2005-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077246-002	DANAZOL	50MG	CAPSULE / ORAL	AB	2007-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077246-003	DANAZOL	100MG	CAPSULE / ORAL	AB	2007-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077246-001	DANAZOL	200MG	CAPSULE / ORAL	AB	2005-09-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A077246-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077246-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077246-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077246-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077246-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077246-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077246-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077246-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077246-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077246-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077246-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077246-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077246-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077246-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077246-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077246-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077246-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077246-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077246-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077246-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077246-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077246-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077246-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077246-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077246-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077246-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077246-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077246-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077246-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077246-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077246-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077246-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077246-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077246-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077246-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077246-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077246-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077246-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077246-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077246-001	AB	1	`1e350fbaab3a…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Danazol	DANAZOL	Chartwell RX, LLC.	55ad6325-16f6-4f0c-a1dc-734847052d0b	2024-10-10	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 077246 application number: ANDA077246
Danazol	DANAZOL	Proficient Rx LP	9e103cf9-f075-48ba-8913-2e44f9442781	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077246 application number: ANDA077246 ndc (product): 71205-862
Danazol	DANAZOL	Lannett Company, Inc.	f2c9b713-aafc-49ca-866e-334d9b5c2e2d	2020-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077246 application number: ANDA077246 ndc (product): 0527-1369

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
0527-1369	Danazol	Danazol	Lannett Company, Inc.	ANDA	Current
0527-1369	Danazol	Danazol	Lannett Company, Inc.	ANDA	Current
0527-1369	Danazol	Danazol	Lannett Company, Inc.	ANDA	Current
0527-1369	Danazol	Danazol	Lannett Company, Inc.	ANDA	Current
68151-2298	Danazol	Danazol	Carilion Materials Management	ANDA	Current
71205-862	Danazol	Danazol	Proficient Rx LP	ANDA	Current