Application 017604

Type: NDA
Sponsor: XSPIRE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	NALFON	FENOPROFEN CALCIUM	CAPSULE;ORAL	EQ 300MG BASE	No	No
003	NALFON	FENOPROFEN CALCIUM	CAPSULE;ORAL	EQ 200MG BASE	Yes	No
004	NALFON	FENOPROFEN CALCIUM	CAPSULE;ORAL	EQ 400MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date
N017604-002	NALFON	FENOPROFEN CALCIUM	EQ 300MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	Approved before 1982
N017604-003	NALFON	FENOPROFEN CALCIUM	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD, Approved before 1982
N017604-004	NALFON	FENOPROFEN CALCIUM	EQ 400MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	2009-07-21

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 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2020-11-12 02:37 UTC	2020-11	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL		RLD, RS	2009-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017604-002	NALFON	EQ 300MG BASE	CAPSULE / ORAL		Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL		RLD, Approved before 1982		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL		RLD, RS	2009-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017604-002	NALFON	EQ 300MG BASE	CAPSULE / ORAL		Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL		RLD, Approved before 1982		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL		RLD, RS	2009-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017604-002	NALFON	EQ 300MG BASE	CAPSULE / ORAL		Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL		RLD, Approved before 1982		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL		RLD, RS	2009-07-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017604-002	NALFON	EQ 300MG BASE	CAPSULE / ORAL		Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	AB	RLD, RS	2009-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017604-002	NALFON	EQ 300MG BASE	CAPSULE / ORAL		Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	AB	RLD, RS	2009-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017604-002	NALFON	EQ 300MG BASE	CAPSULE / ORAL		Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	AB	RLD, RS	2009-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017604-002	NALFON	EQ 300MG BASE	CAPSULE / ORAL		Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	AB	RLD, RS	2009-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017604-002	NALFON	EQ 300MG BASE	CAPSULE / ORAL		Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	AB	RLD, RS	2009-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017604-002	NALFON	EQ 300MG BASE	CAPSULE / ORAL		Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	AB	RLD, RS	2009-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017604-002	NALFON	EQ 300MG BASE	CAPSULE / ORAL		Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL	AB	RLD, Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	AB	RLD, RS	2009-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017604-002	NALFON	EQ 300MG BASE	CAPSULE / ORAL		Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL		RLD, Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	AB	RLD, RS	2009-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017604-002	NALFON	EQ 300MG BASE	CAPSULE / ORAL		Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL		RLD, Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	AB	RLD, RS	2009-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017604-002	NALFON	EQ 300MG BASE	CAPSULE / ORAL		Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017604-003	NALFON	EQ 200MG BASE	CAPSULE / ORAL		RLD, Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017604-004	NALFON	EQ 400MG BASE	CAPSULE / ORAL	AB	RLD, RS	2009-07-21	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	N017604-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017604-004	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017604-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017604-004	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017604-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N017604-004	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017604-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N017604-004	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017604-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017604-004	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017604-003	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017604-004	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017604-003	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017604-004	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017604-003	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017604-004	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017604-004	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017604-004	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017604-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017604-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017604-004	AB	1	`e64feba35796…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenoprofen Calcium	FENOPROFEN CALCIUM	Misemer Pharmaceuticals, Inc.	d33ad329-1ca6-ac2e-e053-2995a90a15c5	2026-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 0276-0503 ndc (product): 0276-0501 ndc (product): 0276-0502

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0276-0501	Fenoprofen Calcium	Fenoprofen Calcium	Misemer Pharmaceuticals, Inc.	NDA	Current
0276-0501	Fenoprofen Calcium	Fenoprofen Calcium	Misemer Pharmaceuticals, Inc.	NDA	Current
0276-0502	Fenoprofen Calcium	Fenoprofen Calcium	Misemer Pharmaceuticals, Inc.	NDA	Current
0276-0503	Fenoprofen Calcium	Fenoprofen Calcium	Misemer Pharmaceuticals, Inc.	NDA	Current
15014-400	Fenoprofen Calcium	Fenoprofen Calcium	Gentex Pharma	NDA AUTHORIZED GENERIC	Current
15014-400	Fenoprofen Calcium	fenoprofen calcium	Gentex Pharma	NDA AUTHORIZED GENERIC	Current
15014-400	Fenoprofen Calcium	fenoprofen calcium	Gentex Pharma	NDA AUTHORIZED GENERIC	Current
15014-400	Fenoprofen Calcium	fenoprofen calcium	Gentex Pharma	NDA AUTHORIZED GENERIC	Current
42195-100	Fenoprofen Calcium	fenoprofen calcium	Xspire Pharma	NDA AUTHORIZED GENERIC	Current
42195-100	Fenoprofen Calcium	fenoprofen calcium	Xspire Pharma, Llc	NDA AUTHORIZED GENERIC	Current
42195-100	Fenoprofen Calcium	fenoprofen calcium	Xspire Pharma	NDA AUTHORIZED GENERIC	Current
42195-100	Fenoprofen Calcium	fenoprofen calcium	Xspire Pharma	NDA AUTHORIZED GENERIC	Current
42195-308	Nalfon	fenoprofen calcium	Xspire Pharma, Llc	NDA	Current
42195-308	Nalfon	fenoprofen calcium	Xspire Pharma	NDA	Current
42195-308	Nalfon	fenoprofen calcium	Xspire Pharma	NDA	Current
42195-308	Nalfon	fenoprofen calcium	Xspire Pharma	NDA	Current
42195-600	Nalfon	fenoprofen calcium	Xspire Pharma, Llc	NDA	Current
42195-600	Nalfon	fenoprofen calcium	Xspire Pharma	NDA	Current
42195-600	Nalfon	fenoprofen calcium	Xspire Pharma	NDA	Current
42195-600	Nalfon	fenoprofen calcium	Xspire Pharma	NDA	Current
50090-3572	Fenoprofen Calcium	fenoprofen calcium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-3572	Fenoprofen Calcium	fenoprofen calcium	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
53217-169	Fenoprofen Calcium	fenoprofen calcium	Aidarex Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
54288-131	FENOPROFEN CALCIUM	FENOPROFEN CALCIUM	BPI Labs LLC	NDA	Current
54288-132	FENOPROFEN CALCIUM	FENOPROFEN CALCIUM	BPI Labs LLC	NDA	Current
55700-853	Nalfon	fenoprofen calcium	Quality Care Products, LLC	NDA	Current
55700-853	Nalfon	fenoprofen calcium	Quality Care Products, LLC	NDA	Current
62250-691	FENOPROFEN	FENOPROFEN CALCIUM	Belcher Pharmaceuticals,LLC	NDA	Current
63187-706	Nalfon	fenoprofen calcium	Proficient Rx LP	NDA	Current
63187-706	Nalfon	fenoprofen calcium	Proficient Rx LP	NDA	Current
63187-706	Nalfon	fenoprofen calcium	Proficient Rx LP	NDA	Current
63187-706	Nalfon	fenoprofen calcium	Proficient Rx LP	NDA	Current
63629-5388	Fenoprofen	fenoprofen	Bryant Ranch Prepack	NDA	Current
63629-7515	Nalfon	fenoprofen calcium	Bryant Ranch Prepack	NDA	Current
63629-7515	Nalfon	fenoprofen calcium	Bryant Ranch Prepack	NDA	Current
63629-7515	Nalfon	fenoprofen calcium	Bryant Ranch Prepack	NDA	Current
63629-7515	Nalfon	fenoprofen calcium	Bryant Ranch Prepack	NDA	Current
63629-8016	Fenoprofen Calcium	fenoprofen calcium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-8016	Fenoprofen Calcium	fenoprofen calcium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-8016	Fenoprofen Calcium	fenoprofen calcium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
69101-400	Fenoprofen Calcium	fenoprofen calcium	Burke Therapeutics, LLC	NDA	Current
69101-400	Fenoprofen Calcium	fenoprofen calcium	Burke Therapeutics, LLC	NDA	Current
69336-113	FENORTHO	FENORTHO	Sterling Knight Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
69336-113	FENORTHO	FENORTHO	Sterling Knight Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
69336-124	FENOPROFEN CALCIUM	FENOPROFEN CALCIUM	Sterling Knight Pharmaceuticals	NDA	Current
69336-124	FENOPROFEN CALCIUM	FENOPROFEN CALCIUM	Sterling Knight Pharmaceuticals	NDA	Current
71335-0307	Fenoprofen Calcium	fenoprofen calcium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-0307	Fenoprofen Calcium	fenoprofen calcium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-0307	Fenoprofen Calcium	fenoprofen calcium	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-0805	Nalfon	fenoprofen calcium	Bryant Ranch Prepack	NDA	Current
71335-0805	Nalfon	fenoprofen calcium	Bryant Ranch Prepack	NDA	Current
71335-0805	Nalfon	fenoprofen calcium	Bryant Ranch Prepack	NDA	Current
71335-1302	Nalfon	fenoprofen calcium	Bryant Ranch Prepack	NDA	Current
71335-1302	Nalfon	fenoprofen calcium	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80366	SUPPL	2024-11-25
80365	SUPPL	2024-11-25
80339	SUPPL	2024-11-25
67332	SUPPL	2021-05-03
67224	SUPPL	2021-04-29
13868	SUPPL	2016-05-11
11048	SUPPL	2016-05-11
43596	ORIG	2009-11-19
11047	SUPPL	2009-07-24
665	SUPPL	2009-07-23
11046	SUPPL	2007-08-14
664	SUPPL	2007-08-14
13867	SUPPL	2006-01-20
11045	SUPPL	2006-01-20