Application 019012

Type: NDA
Sponsor: J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NUPRIN	IBUPROFEN	TABLET;ORAL	200MG	No	No
002	NUPRIN	IBUPROFEN	TABLET;ORAL	200MG	No	No
003	MOTRIN IB	IBUPROFEN	TABLET;ORAL	200MG	Yes	No
004	MOTRIN MIGRAINE PAIN	IBUPROFEN	TABLET;ORAL	200MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019012-001	NUPRIN	IBUPROFEN	200MG	TABLET / ORAL		1984-05-18
N019012-002	NUPRIN	IBUPROFEN	200MG	TABLET / ORAL		1987-07-29
N019012-003	MOTRIN IB	IBUPROFEN	200MG	TABLET / ORAL	RLD	1990-12-17
N019012-004	MOTRIN MIGRAINE PAIN	IBUPROFEN	200MG	TABLET / ORAL		2000-02-25

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 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019012-001	NUPRIN	200MG	TABLET / ORAL		1984-05-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019012-002	NUPRIN	200MG	TABLET / ORAL		1987-07-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019012-003	MOTRIN IB	200MG	TABLET / ORAL	RLD	1990-12-17	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019012-004	MOTRIN MIGRAINE PAIN	200MG	TABLET / ORAL		2000-02-25	`ea99ee380514…`

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
Motrin IB	IBUPROFEN	Savings Distributors LLC	56846774-8413-c306-e063-6394a90a2be8	2026-01-01	Warnings	Exact identifier application applno (NDA): 019012 application number: NDA019012
Motrin IB	IBUPROFEN	Navajo Manufacturing Company Inc.	f70c1b68-61c8-b333-e053-6294a90aadaa	2023-03-16	Warnings	Exact identifier application applno (NDA): 019012 application number: NDA019012

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29485-1465	Motrin IB	Ibuprofen	Mechanical Servants, LLC	NDA	Current
29485-1465	Motrin IB	Ibuprofen	Mechanical Servants, LLC	NDA	Current
29485-1465	Motrin IB	Ibuprofen	Mechanical Servants, LLC	NDA	Current
29485-1465	Motrin IB	Ibuprofen	Mechanical Servants, LLC	NDA	Current
29485-7006	Motrin IB	Ibuprofen	Mechanical Servants, LLC	NDA	Current
29485-7006	Motrin IB	Ibuprofen	Mechanical Servants, LLC	NDA	Current
29485-7938	Motrin IB	Ibuprofen	Mechanical Servants, LLC	NDA	Current
29485-7938	Motrin IB	Ibuprofen	Mechanical Servants, LLC	NDA	Current
50580-110	Motrin IB	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-110	Motrin IB	Ibuprofen	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
66715-9712	Motrin IB	Ibuprofen	Lil' Drug Store Products, Inc.	NDA	Current
67751-165	Motrin IB	IBUPROFEN	Navajo Manufacturing Company Inc.	NDA	Current
67751-165	Motrin IB	IBUPROFEN	Navajo Manufacturing Company Inc.	NDA	Current
73097-008	Motrin IB	IBUPROFEN	Savings Distributors LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
69411	SUPPL	2021-11-24
69333	SUPPL	2021-11-17
67213	SUPPL	2021-04-28
67209	SUPPL	2021-04-28
47587	SUPPL	2017-03-20
47586	SUPPL	2017-03-20
47577	SUPPL	2017-03-17
47576	SUPPL	2017-03-17
45096	SUPPL	2016-08-22
45145	SUPPL	2016-08-18
40861	SUPPL	2015-11-05
20197	SUPPL	2015-11-05
33689	SUPPL	2012-03-27
16174	SUPPL	2010-10-26
1203	SUPPL	2009-05-01
1202	SUPPL	2007-11-26
16173	SUPPL	2006-12-28
1201	SUPPL	2006-02-22
16172	SUPPL	2003-10-31
33688	SUPPL	2003-04-16
40860	SUPPL	2002-05-14
16171	SUPPL	2000-02-25
11414	SUPPL	2000-02-25