Application 208963

Type: ANDA
Sponsor: ZYDUS PHARMS

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 43.

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
A208963-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16
A208963-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16
A208963-003	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16
A208963-004	FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208963-001	AB
A208963-002	AB
A208963-003	AB
A208963-004	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 · 172 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
2026-09-14 22:38:34	2026-08	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208963-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2017-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208963-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2017-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208963-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2017-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208963-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2017-02-16	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208963-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208963-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208963-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208963-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208963-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208963-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208963-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208963-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208963-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208963-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208963-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208963-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208963-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208963-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208963-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208963-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208963-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208963-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208963-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208963-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208963-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208963-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208963-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208963-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208963-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208963-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208963-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208963-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208963-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208963-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208963-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208963-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208963-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208963-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208963-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208963-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208963-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208963-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208963-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208963-004	AB	1	`5bbf6a4d5a75…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fluconazole	FLUCONAZOLE	Preferred Pharmaceuticals Inc.	16b6fba0-b96f-4252-a70d-31dc61400298	2026-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	A-S Medication Solutions	7961c029-746c-48c3-888b-8f8344102873	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	67af604c-928f-468b-ba27-ad45e95d3e7e	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	7259671f-a703-4a2a-81db-9a4839b34072	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963 ndc (product): 71335-0769
fluconazole	FLUCONAZOLE	Zydus Pharmaceuticals (USA) Inc.	d1364455-1537-46d4-b093-38cca3be778f	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	A-S Medication Solutions	1a8bd42a-2bce-4b41-8678-67033e7707dd	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
FLUCONAZOLE	FLUCONAZOLE	direct rx	b3db505a-9677-6f5a-e053-2a95a90a13d4	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963 ndc (product): 72189-140 ndc (product): 72189-149
fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	715c53f0-2aea-1f24-e053-2995a90ad463	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	Zydus Lifesciences Limited	0adb2f88-8a6f-4f33-9e2d-73f537e05313	2024-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
Fluconazole	FLUCONAZOLE	Direct Rx	69f199fa-bb92-4837-8b12-427a1c71f622	2024-01-09	Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	A-S Medication Solutions	08a54805-4fdf-48fd-bc3e-e9fa38f3c691	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	Proficient Rx LP	f232600e-70ce-4001-b9da-31442f0920b9	2020-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963
fluconazole	FLUCONAZOLE	Proficient Rx LP	7c8bb5ff-37e7-4f5e-8ea7-12269b2c7fd3	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208963 application number: ANDA208963

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 2 of 2 · 91 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71335-0769	fluconazole	fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-0769	fluconazole	fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-0769	fluconazole	fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1175	fluconazole	fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1175	fluconazole	fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1175	fluconazole	fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1175	fluconazole	fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1175	fluconazole	fluconazole	Bryant Ranch Prepack	ANDA	Current
72189-140	FLUCONAZOLE	FLUCONAZOLE	direct rx	ANDA	Current
72189-149	fluconazole	fluconazole	direct rx	ANDA	Current
72189-149	fluconazole	fluconazole	direct rx	ANDA	Current