Application 208111

Type: ANDA
Sponsor: PERRIGO UK FINCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE	SPRAY, METERED;NASAL	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	No	No

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

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
A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB		2021-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208111-001	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.

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	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208111-001	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	0.137MG/SPRAY;0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2021-02-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208111-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208111-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208111-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208111-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208111-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208111-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208111-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208111-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208111-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208111-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208111-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208111-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208111-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208111-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208111-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208111-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208111-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208111-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208111-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208111-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208111-001	AB	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208111-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208111-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208111-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208111-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208111-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208111-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208111-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208111-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208111-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208111-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208111-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208111-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208111-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208111-001	AB	1	`a50c72e98297…`

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
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE	Bryant Ranch Prepack	e95227ff-5747-4a35-a1b8-b1019fe1e61c	2025-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208111 application number: ANDA208111
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE	Bryant Ranch Prepack	1a930a09-db26-40aa-bb05-123a0d7182bc	2025-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208111 application number: ANDA208111 ndc (product): 63629-8612
AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE	Padagis Israel Pharmaceuticals Ltd	625ffdd0-8486-49af-8e77-6aa663be5ac7	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208111 application number: ANDA208111 ndc (product): 45802-066

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-066	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride, fluticasone propionate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-066	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride, fluticasone propionate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-066	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride, fluticasone propionate	Perrigo New York Inc	ANDA	Current
63629-8612	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride, fluticasone propionate	Bryant Ranch Prepack	ANDA	Current
63629-8612	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride, fluticasone propionate	Bryant Ranch Prepack	ANDA	Current
63629-8612	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride, fluticasone propionate	Bryant Ranch Prepack	ANDA	Current