Application 078492

Type: ANDA
Sponsor: WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	SPRAY, METERED;NASAL	0.05MG/SPRAY	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078492-001	FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB		2012-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078492-001	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 2 · 41 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	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078492-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2012-01-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A078492-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078492-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078492-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078492-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078492-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078492-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078492-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078492-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078492-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078492-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078492-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078492-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078492-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078492-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078492-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078492-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078492-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078492-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078492-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078492-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078492-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078492-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078492-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078492-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078492-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078492-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078492-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078492-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078492-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078492-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078492-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078492-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078492-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078492-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078492-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078492-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078492-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078492-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078492-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078492-001	AB	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluticasone Propionate spray, metered	FLUTICASONE PROPIONATE	Chartwell RX, LLC	71a2609f-c4b9-49b0-8185-83c20c22e1d6	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078492 application number: ANDA078492
Fluticasone	FLUTICASONE PROPIONATE	NuCare Pharmaceuticals,Inc.	549ff4f2-fa68-3dd8-e054-00144ff8d46c	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078492 application number: ANDA078492 ndc (product): 68071-1638

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-602	Fluticasone	Fluticasone Propionate	Medsource Pharmaceuticals	ANDA	Current
50436-2640	Fluticasone	Fluticasone Propionate	Unit Dose Services	ANDA	Current
55700-680	FLUTICASONE	fluticasone propionate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-680	FLUTICASONE	fluticasone propionate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-680	FLUTICASONE	fluticasone propionate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60432-264	FLUTICASONE	fluticasone propionate	Morton Grove Pharmaceuticals, Inc.	ANDA	Current
61919-004	FLUTICASONE	FLUTICASONE	Direct RX	ANDA	Current
61919-004	FLUTICASONE	FLUTICASONE	Direct RX	ANDA	Current
68071-1638	Fluticasone	Fluticasone Propionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1638	Fluticasone	Fluticasone Propionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7788	FLUTICASONE	fluticasone propionate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7788	FLUTICASONE	fluticasone propionate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7788	FLUTICASONE	fluticasone propionate	Preferred Pharmaceuticals Inc.	ANDA	Current
71205-443	FLUTICASONE	fluticasone propionate	Proficient Rx LP	ANDA	Current
71205-443	FLUTICASONE	fluticasone propionate	Proficient Rx LP	ANDA	Current