Application 076658

Type: ANDA
Sponsor: DR REDDYS LABS INC

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 1.

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
A076658-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29
A076658-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29
A076658-003	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29
A076658-004	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
A076658-001	AB
A076658-002	AB
A076658-003	AB
A076658-004	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 · 164 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	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076658-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2004-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076658-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2004-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076658-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2004-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076658-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2004-07-29	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A076658-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076658-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076658-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076658-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076658-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076658-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076658-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076658-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076658-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076658-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076658-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076658-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076658-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076658-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076658-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076658-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076658-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076658-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076658-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076658-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076658-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076658-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076658-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076658-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076658-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076658-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076658-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076658-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076658-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076658-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076658-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076658-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076658-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076658-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076658-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076658-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076658-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076658-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076658-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076658-004	AB	1	`d06236e962d9…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	Cardinal Health 107, LLC	f1bfba3a-5b18-41c0-9084-b1f26bb93ef2	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076658 application number: ANDA076658 ndc (product): 55154-3400 ndc (product): 55154-7875
Fluconazole	FLUCONAZOLE	Sportpharm LLC	8a4d6d9e-02ae-42e4-83ec-f5c4e135273b	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076658 application number: ANDA076658
Fluconazole	FLUCONAZOLE	Major Pharmaceuticals	13184b13-e252-4b4d-a3e2-cfc4ad3d55b7	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076658 application number: ANDA076658 ndc (product): 0904-6500 ndc (product): 0904-6501
Fluconazole	FLUCONAZOLE	Dr. Reddy's Laboratories Limited	d7fa1d79-4cd3-4a55-b74b-b31e82e616a3	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076658 application number: ANDA076658 ndc (product): 55111-143 ndc (product): 55111-145 ndc (product): 55111-146 ndc (product): 55111-144
FLUCONAZOLE	FLUCONAZOLE	direct rx	b3db505a-9677-6f5a-e053-2a95a90a13d4	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076658 application number: ANDA076658 ndc (product): 72189-143
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	a499c43e-0454-4a8c-a547-31e9816babdd	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076658 application number: ANDA076658 ndc (product): 71335-1448
Fluconazole	FLUCONAZOLE	Direct Rx	69f199fa-bb92-4837-8b12-427a1c71f622	2024-01-09	Adverse reactions	Exact identifier ndc (product): 61919-380

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6500	Fluconazole	Fluconazole	Major Pharmaceuticals	ANDA	Current
0904-6500	Fluconazole	Fluconazole	Major Pharmaceuticals	ANDA	Current
0904-6500	Fluconazole	Fluconazole	Major Pharmaceuticals	ANDA	Current
0904-6500	Fluconazole	Fluconazole	Major Pharmaceuticals	ANDA	Current
0904-6500	Fluconazole	Fluconazole	Major Pharmaceuticals	ANDA	Current
0904-6501	Fluconazole	Fluconazole	Major Pharmaceuticals	ANDA	Current
0904-6501	Fluconazole	Fluconazole	Major Pharmaceuticals	ANDA	Current
0904-6501	Fluconazole	Fluconazole	Major Pharmaceuticals	ANDA	Current
0904-6501	Fluconazole	Fluconazole	Major Pharmaceuticals	ANDA	Current
0904-6501	Fluconazole	Fluconazole	Major Pharmaceuticals	ANDA	Current
55111-143	Fluconazole	Fluconazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-143	Fluconazole	Fluconazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-143	Fluconazole	Fluconazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-143	Fluconazole	Fluconazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-144	Fluconazole	Fluconazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-144	Fluconazole	Fluconazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-144	Fluconazole	Fluconazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-144	Fluconazole	Fluconazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-145	Fluconazole	Fluconazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-145	Fluconazole	Fluconazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-145	Fluconazole	Fluconazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-145	Fluconazole	Fluconazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-146	Fluconazole	Fluconazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-146	Fluconazole	Fluconazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-146	Fluconazole	Fluconazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55111-146	Fluconazole	Fluconazole	Dr. Reddy's Laboratories Limited	ANDA	Current
55154-3400	Fluconazole	Fluconazole	Cardinal Health	ANDA	Current
55154-3400	Fluconazole	Fluconazole	Cardinal Health	ANDA	Current
55154-3400	Fluconazole	Fluconazole	Cardinal Health	ANDA	Current
55154-7875	Fluconazole	Fluconazole	Cardinal Health	ANDA	Current
55154-7875	Fluconazole	Fluconazole	Cardinal Health	ANDA	Current
55154-7875	Fluconazole	Fluconazole	Cardinal Health	ANDA	Current
55700-916	Fluconazole	Fluconazole	Quality Care Products, LLC	ANDA	Current
61919-380	Fluconazole	Fluconazole	Direct Rx	ANDA	Current
61919-380	Fluconazole	Fluconazole	Direct Rx	ANDA	Current
61919-380	Fluconazole	Fluconazole	Direct Rx	ANDA	Current
68071-3344	Fluconazole	Fluconazole	Nucare Pharmaceuticals,Inc	ANDA	Current
68788-8938	Fluconazole	Fluconazole	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9988	Fluconazole	Fluconazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
71335-1448	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1448	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1448	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
72189-143	FLUCONAZOLE	FLUCONAZOLE	direct rx	ANDA	Current
72189-143	FLUCONAZOLE	FLUCONAZOLE	direct rx	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8944	ORIG	2004-07-30