Application 076665

Type: ANDA
Sponsor: CHARTWELL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUCONAZOLE	FLUCONAZOLE	TABLET;ORAL	50MG	No	No
002	FLUCONAZOLE	FLUCONAZOLE	TABLET;ORAL	100MG	No	No
003	FLUCONAZOLE	FLUCONAZOLE	TABLET;ORAL	150MG	No	No
004	FLUCONAZOLE	FLUCONAZOLE	TABLET;ORAL	200MG	No	No

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

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	Approval date
A076665-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29
A076665-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29
A076665-003	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29
A076665-004	FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A076665-001	AB
A076665-002	AB
A076665-003	AB
A076665-004	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 5 · 168 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	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076665-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076665-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076665-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076665-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A076665-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076665-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076665-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076665-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076665-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076665-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076665-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076665-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076665-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076665-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076665-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076665-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076665-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076665-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076665-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076665-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076665-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076665-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076665-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076665-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076665-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076665-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076665-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076665-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076665-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076665-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076665-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076665-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076665-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076665-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076665-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076665-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076665-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076665-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076665-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076665-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076665-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076665-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076665-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076665-004	AB	1	`d8e5a09893c0…`

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
FLUCONAZOLE	FLUCONAZOLE	HAWAII REPACK, INC.	8aa296e2-ad8d-42f6-8b41-468e2b9cdfb8	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076665 application number: ANDA076665
FLUCONAZOLE	FLUCONAZOLE	Chartwell RX, LLC	f86ea347-78f5-43b8-9574-a52569a4237b	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076665 application number: ANDA076665 ndc (product): 62135-132 ndc (product): 62135-133 ndc (product): 62135-130 ndc (product): 62135-131
FLUCONAZOLE	FLUCONAZOLE	Asclemed USA, Inc.	3208dc64-6117-4b2d-9008-76a819cef7d7	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076665 application number: ANDA076665

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
62135-130	FLUCONAZOLE	FLUCONAZOLE	Chartwell RX, LLC	ANDA	Current
62135-131	FLUCONAZOLE	FLUCONAZOLE	Chartwell RX, LLC	ANDA	Current
62135-132	FLUCONAZOLE	FLUCONAZOLE	Chartwell RX, LLC	ANDA	Current
62135-133	FLUCONAZOLE	FLUCONAZOLE	Chartwell RX, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31153	ORIG	2004-07-30