Application 079150

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUCONAZOLE	FLUCONAZOLE	FOR SUSPENSION;ORAL	50MG/5ML	No	No
002	FLUCONAZOLE	FLUCONAZOLE	FOR SUSPENSION;ORAL	200MG/5ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A079150-001	FLUCONAZOLE	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB		2009-09-18
A079150-002	FLUCONAZOLE	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB		2009-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A079150-001	AB
A079150-002	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 1 of 3 · 84 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	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079150-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079150-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2009-09-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A079150-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A079150-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079150-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079150-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079150-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079150-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079150-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079150-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079150-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079150-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079150-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079150-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079150-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079150-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079150-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079150-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079150-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079150-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079150-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079150-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079150-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079150-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079150-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079150-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079150-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079150-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079150-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079150-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079150-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079150-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079150-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079150-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079150-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079150-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079150-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079150-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079150-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079150-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079150-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079150-002	AB	1	`bb7c543d1eb4…`

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	Rising Pharma Holdings, Inc.	ccbe0991-27a1-4ddb-bfc7-1b3422e53390	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079150 application number: ANDA079150 ndc (product): 57237-149 ndc (product): 57237-150
Fluconazole	FLUCONAZOLE	NorthStar Rx LLC	afde17e7-b95b-4cd5-97eb-e361724014bd	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079150 application number: ANDA079150 ndc (product): 16714-695 ndc (product): 16714-696
Fluconazole	FLUCONAZOLE	Aurobindo Pharma Limited	bf588f7e-89de-4b4e-8d33-c1ff2be1b34e	2024-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079150 application number: ANDA079150 ndc (product): 65862-300 ndc (product): 65862-299

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-695	Fluconazole	Fluconazole	NorthStar Rx LLC	ANDA	Current
16714-695	Fluconazole	Fluconazole	NorthStar Rx LLC	ANDA	Current
16714-695	Fluconazole	Fluconazole	NorthStar Rx LLC	ANDA	Current
16714-695	Fluconazole	Fluconazole	NorthStar Rx LLC	ANDA	Current
16714-695	Fluconazole	Fluconazole	NorthStar Rx LLC	ANDA	Current
16714-695	Fluconazole	Fluconazole	NorthStar Rx LLC	ANDA	Current
16714-695	Fluconazole	Fluconazole	NorthStar Rx LLC	ANDA	Current
16714-696	Fluconazole	Fluconazole	NorthStar Rx LLC	ANDA	Current
16714-696	Fluconazole	Fluconazole	NorthStar Rx LLC	ANDA	Current
16714-696	Fluconazole	Fluconazole	NorthStar Rx LLC	ANDA	Current
16714-696	Fluconazole	Fluconazole	NorthStar Rx LLC	ANDA	Current
16714-696	Fluconazole	Fluconazole	NorthStar Rx LLC	ANDA	Current
16714-696	Fluconazole	Fluconazole	NorthStar Rx LLC	ANDA	Current
16714-696	Fluconazole	Fluconazole	NorthStar Rx LLC	ANDA	Current
57237-149	Fluconazole	Fluconazole	Rising Health, LLC	ANDA	Current
57237-149	Fluconazole	Fluconazole	Rising Health, LLC	ANDA	Current
57237-149	Fluconazole	Fluconazole	Rising Health, LLC	ANDA	Current
57237-149	Fluconazole	Fluconazole	Rising Health, LLC	ANDA	Current
57237-149	Fluconazole	Fluconazole	Rising Health, LLC	ANDA	Current
57237-149	Fluconazole	Fluconazole	Rising Health, LLC	ANDA	Current
57237-149	Fluconazole	Fluconazole	Rising Health, LLC	ANDA	Current
57237-149	Fluconazole	Fluconazole	Rising Health, LLC	ANDA	Current
57237-150	Fluconazole	Fluconazole	Rising Health, LLC	ANDA	Current
57237-150	Fluconazole	Fluconazole	Rising Health, LLC	ANDA	Current
57237-150	Fluconazole	Fluconazole	Rising Health, LLC	ANDA	Current
57237-150	Fluconazole	Fluconazole	Rising Health, LLC	ANDA	Current
57237-150	Fluconazole	Fluconazole	Rising Health, LLC	ANDA	Current
57237-150	Fluconazole	Fluconazole	Rising Health, LLC	ANDA	Current
57237-150	Fluconazole	Fluconazole	Rising Health, LLC	ANDA	Current
57237-150	Fluconazole	Fluconazole	Rising Health, LLC	ANDA	Current
65862-299	Fluconazole	Fluconazole	Aurobindo Pharma Limited	ANDA	Current
65862-299	Fluconazole	Fluconazole	Aurobindo Pharma Limited	ANDA	Current
65862-299	Fluconazole	Fluconazole	Aurobindo Pharma Limited	ANDA	Current
65862-299	Fluconazole	Fluconazole	Aurobindo Pharma Limited	ANDA	Current
65862-299	Fluconazole	Fluconazole	Aurobindo Pharma Limited	ANDA	Current
65862-299	Fluconazole	Fluconazole	Aurobindo Pharma Limited	ANDA	Current
65862-300	Fluconazole	Fluconazole	Aurobindo Pharma Limited	ANDA	Current
65862-300	Fluconazole	Fluconazole	Aurobindo Pharma Limited	ANDA	Current
65862-300	Fluconazole	Fluconazole	Aurobindo Pharma Limited	ANDA	Current
65862-300	Fluconazole	Fluconazole	Aurobindo Pharma Limited	ANDA	Current
65862-300	Fluconazole	Fluconazole	Aurobindo Pharma Limited	ANDA	Current
65862-300	Fluconazole	Fluconazole	Aurobindo Pharma Limited	ANDA	Current