Application 077538

Type: ANDA
Sponsor: APOTEX INC

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
A077538-001	FLUTICASONE PROPIONATE	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB		2007-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077538-001	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	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077538-001	FLUTICASONE PROPIONATE	0.05MG/SPRAY	SPRAY, METERED / NASAL	AB	2007-09-12	`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	A077538-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077538-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077538-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077538-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077538-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077538-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077538-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077538-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077538-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077538-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077538-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077538-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077538-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077538-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077538-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077538-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077538-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077538-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077538-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077538-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077538-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077538-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077538-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077538-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077538-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077538-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077538-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077538-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077538-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077538-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077538-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077538-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077538-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077538-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077538-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077538-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077538-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077538-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077538-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077538-001	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluticasone Propionate	FLUTICASONE PROPIONATE	Preferred Pharmaceuticals, Inc.	4916301d-bcc8-4cd1-86b4-7bf0aecfbf68	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538 ndc (product): 68788-9678
Fluticasone Propionate	FLUTICASONE PROPIONATE	Direct_RX	8b9f7474-8d89-b3e6-e053-2995a90aeddb	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538 ndc (product): 72189-004
Fluticasone Propionate	FLUTICASONE PROPIONATE	IPG Pharmaceuticals, Inc.	f1965bd9-1851-4be5-bbe0-71dd59e034d5	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538
Fluticasone Propionate	FLUTICASONE PROPIONATE	REMEDYREPACK INC.	d781dd49-ed8d-4204-99ac-a3b632d7640a	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538 ndc (product): 70518-1655
Fluticasone Propionate	FLUTICASONE PROPIONATE	Golden State Medical Supply, Inc.	db857d81-4b1e-42b8-972a-5bb8735d60f8	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538 ndc (product): 60429-195
Fluticasone Propionate	FLUTICASONE PROPIONATE	Apotex Corp.	3830675d-b45e-fc97-1f73-674b1fc38c80	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538 ndc (product): 60505-0829
Fluticasone Propionate	FLUTICASONE PROPIONATE	Asclemed USA, Inc.	504397c5-6f9f-45cc-9cc9-997da0a80364	2025-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538
Fluticasone Propionate	FLUTICASONE PROPIONATE	Quality Care Products, LLC	1bcf25b7-25bc-489e-b5b6-3ae2b3babf6e	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538 ndc (product): 55700-714
Fluticasone Propionate	FLUTICASONE PROPIONATE	Proficient Rx LP	1d5d5f27-6565-4e7b-9923-faa3d15cb1c4	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538 ndc (product): 63187-638
Fluticasone Propionate	FLUTICASONE PROPIONATE	A-S Medication Solutions	e2df3810-3b92-4678-8f62-683c656b1de9	2023-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077538 application number: ANDA077538 ndc (product): 50090-0968

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 43 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-653	Fluticasone Propionate	Fluticasone Propionate	Blenheim Pharmacal, Inc.	ANDA	Current
50090-0968	Fluticasone Propionate	Fluticasone Propionate	A-S Medication Solutions	ANDA	Current
50090-0968	Fluticasone Propionate	Fluticasone Propionate	A-S Medication Solutions	ANDA	Current
50090-0968	Fluticasone Propionate	Fluticasone Propionate	A-S Medication Solutions	ANDA	Current
50090-2267	Fluticasone Propionate	Fluticasone Propionate	A-S Medication Solutions	ANDA	Current
50090-2267	Fluticasone Propionate	Fluticasone Propionate	A-S Medication Solutions	ANDA	Current
50090-2267	Fluticasone Propionate	Fluticasone Propionate	A-S Medication Solutions	ANDA	Current
50090-3679	Fluticasone Propionate	Fluticasone Propionate	A-S Medication Solutions	ANDA	Current
50090-3679	Fluticasone Propionate	Fluticasone Propionate	A-S Medication Solutions	ANDA	Current
53002-7691	Fluticasone Propionate	Fluticasone Propionate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-7691	Fluticasone Propionate	Fluticasone Propionate	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-714	Fluticasone Propionate	Fluticasone Propionate	Quality Care Products, LLC	ANDA	Current
55700-714	Fluticasone Propionate	Fluticasone Propionate	Quality Care Products, LLC	ANDA	Current
59088-392	Ticanase	Fluticasone Propionate	PureTek Corporation	ANDA	Current
59088-392	Ticanase	Fluticasone Propionate	PureTek Corporation	ANDA	Current
60429-195	Fluticasone Propionate	Fluticasone Propionate	Golden State Medical Supply, Inc.	ANDA	Current
60429-195	Fluticasone Propionate	Fluticasone Propionate	Golden State Medical Supply, Inc.	ANDA	Current
60429-195	Fluticasone Propionate	Fluticasone Propionate	Golden State Medical Supply	ANDA	Current
60429-195	Fluticasone Propionate	Fluticasone Propionate	Golden State Medical Supply, Inc.	ANDA	Current
60429-195	Fluticasone Propionate	Fluticasone Propionate	Golden State Medical Supply, Inc.	ANDA	Current
60505-0829	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-0829	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-0829	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-0829	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-0829	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-0829	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-0829	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-0847	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
60505-0847	Fluticasone Propionate	Fluticasone Propionate	Apotex Corp.	ANDA	Current
63187-638	Fluticasone Propionate	Fluticasone Propionate	Proficient Rx LP	ANDA	Current
63187-638	Fluticasone Propionate	Fluticasone Propionate	Proficient Rx LP	ANDA	Current
63187-638	Fluticasone Propionate	Fluticasone Propionate	Proficient Rx LP	ANDA	Current
63187-638	Fluticasone Propionate	Fluticasone Propionate	Proficient Rx LP	ANDA	Current
68071-2582	Fluticasone Propionate	Fluticasone Propionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9678	Fluticasone Propionate	Fluticasone Propionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9678	Fluticasone Propionate	Fluticasone Propionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9678	Fluticasone Propionate	Fluticasone Propionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9678	Fluticasone Propionate	Fluticasone Propionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
69621-392	Ticaspray	Fluticasone Propionate	Shoreline Pharmaceuticals, Inc.	ANDA	Current
70518-1655	Fluticasone Propionate	Fluticasone Propionate	REMEDYREPACK INC.	ANDA	Current
70518-1655	Fluticasone Propionate	Fluticasone Propionate	REMEDYREPACK INC.	ANDA	Current
70518-1655	Fluticasone Propionate	Fluticasone Propionate	REMEDYREPACK INC.	ANDA	Current
72189-004	Fluticasone Propionate	Fluticasone Propionate	Direct_RX	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43125	ORIG	2011-12-14