Application 203433

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	POWDER;INHALATION	0.1MG/INH;EQ 0.05MG BASE/INH	No	No
002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	POWDER;INHALATION	0.25MG/INH;EQ 0.05MG BASE/INH	No	No
003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	POWDER;INHALATION	0.5MG/INH;EQ 0.05MG BASE/INH	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17
A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17
A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203433-001	AB
A203433-002	AB
A203433-003	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 · 87 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	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203433-002	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.25MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203433-003	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.5MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2023-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203433-001	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	0.1MG/INH;EQ 0.05MG BASE/INH	POWDER / INHALATION	AB	2020-12-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 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	A203433-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203433-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203433-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203433-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203433-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203433-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203433-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203433-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203433-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203433-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203433-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203433-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203433-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203433-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203433-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203433-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203433-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203433-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203433-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203433-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203433-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203433-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203433-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203433-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203433-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203433-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203433-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203433-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203433-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203433-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203433-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203433-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203433-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203433-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203433-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203433-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203433-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203433-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203433-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203433-001	AB	1	`8072bd15b7f6…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fluticasone propionate and salmeterol	FLUTICASONE PROPIONATE AND SALMETEROL	REMEDYREPACK INC.	7fecae39-f966-4da5-99f6-4d9428d1b147	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203433 application number: ANDA203433
fluticasone propionate and salmeterol	FLUTICASONE PROPIONATE AND SALMETEROL	REMEDYREPACK INC.	7fdaa6db-82bd-4941-be11-ee80a0784d55	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203433 application number: ANDA203433
fluticasone propionate and salmeterol	FLUTICASONE PROPIONATE AND SALMETEROL	Preferred Pharmaceuticals Inc.	0dea4818-e9d6-42f2-a702-90419fff2695	2025-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203433 application number: ANDA203433
fluticasone propionate and salmeterol	FLUTICASONE PROPIONATE AND SALMETEROL	Preferred Pharmaceuticals Inc.	08870f40-8c46-4d91-a101-c3cbb894ca49	2025-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203433 application number: ANDA203433
fluticasone propionate and salmeterol	FLUTICASONE PROPIONATE AND SALMETEROL	Hikma Pharmaceuticals USA Inc.	f9fcfc90-3677-4a9b-900e-44417d50d507	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203433 application number: ANDA203433 ndc (product): 0054-0327 ndc (product): 0054-0326

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0326	fluticasone propionate and salmeterol	fluticasone propionate and salmeterol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0326	fluticasone propionate and salmeterol	fluticasone propionate and salmeterol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0326	fluticasone propionate and salmeterol	fluticasone propionate and salmeterol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0326	fluticasone propionate and salmeterol	fluticasone propionate and salmeterol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0326	fluticasone propionate and salmeterol	fluticasone propionate and salmeterol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0327	fluticasone propionate and salmeterol	fluticasone propionate and salmeterol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0327	fluticasone propionate and salmeterol	fluticasone propionate and salmeterol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0327	fluticasone propionate and salmeterol	fluticasone propionate and salmeterol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0327	fluticasone propionate and salmeterol	fluticasone propionate and salmeterol	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0327	fluticasone propionate and salmeterol	fluticasone propionate and salmeterol	Hikma Pharmaceuticals USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68763	SUPPL	2021-09-24