Application 079205

Type: ANDA
Sponsor: MARKSANS PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN	IBUPROFEN	CAPSULE;ORAL	EQ 200MG FREE ACID AND POTASSIUM SALT	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A079205-001	IBUPROFEN	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL			2009-06-26

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079205-001	IBUPROFEN	EQ 200MG FREE ACID AND POTASSIUM SALT	CAPSULE / ORAL	2009-06-26	`f41ea6bd6efb…`

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ibuprofen	IBUPROFEN	TIME CAP LABORATORIES, INC.	059cb22f-f6db-5d03-e063-6294a90a9ec1	2023-10-27	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205
Ibuprofen	IBUPROFEN CAPSULES 200 MG	TIME CAP LABORATORIES, INC.	c7c51cf3-9e95-f8d0-e053-2995a90a7371	2023-09-18	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205 ndc (product): 49483-133
Ibuprofen	IBUPROFEN	MARKSANS PHARMA LIMITED	403ec259-3be1-4e0b-ab7b-fee213b7eabe	2023-04-03	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205 ndc (product): 25000-062 ndc (product): 25000-133
Ibuprofen	IBUPROFEN	DOLGENCORP, INC.	df321783-73cb-55bf-e053-2a95a90a4ce2	2022-07-07	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205 ndc (product): 55910-399
Ibuprofen 200 mg	IBUPROFEN	Allegiant Health	8ba06ba0-bfe9-4626-af65-dae4d6a3a2ad	2021-12-06	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205 ndc (product): 69168-368
Sound Body Ibuprofen	IBUPROFEN 200 MG	Allegiant Health	73af6385-3081-49cc-83de-f872a47c31dc	2017-11-15	Warnings	Exact identifier application applno (ANDA): 079205 application number: ANDA079205 ndc (product): 69168-914

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 · 59 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0003	IBUPROFEN	ibuprofen	Walgreen Company	ANDA	Current
0363-1610	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
0363-1610	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
0363-1610	IBUPROFEN	IBUPROFEN	WALGREENS	ANDA	Current
11673-683	Ibuprofen Mini	Ibuprofen Mini 200 mg	TARGET CORPORATION	ANDA	Current
11673-992	IBUPROFEN	IBUPROFEN	TARGET CORPORATION	ANDA	Current
11673-992	IBUPROFEN	IBUPROFEN	TARGET CORPORATION	ANDA	Current
11673-992	IBUPROFEN	IBUPROFEN	TARGET CORPORATION	ANDA	Current
11673-992	IBUPROFEN	IBUPROFEN	TARGET CORPORATION	ANDA	Current
25000-062	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
25000-062	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
25000-133	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
25000-133	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
25000-133	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
25000-133	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
25000-133	Ibuprofen	Ibuprofen	MARKSANS PHARMA LIMITED	ANDA	Current
41163-185	Ibuprofen	Ibuprofen	SuperValu Inc.	ANDA	Current
41226-610	IBUPROFEN	IBUPROFEN	Kroger Company	ANDA	Current
49035-133	Equate Ibuprofen	Ibuprofen	Walmart stores Inc	ANDA	Current
49483-133	Ibuprofen	Ibuprofen Capsules 200 mg	TIME CAP LABORATORIES, INC.	ANDA	Current
49483-133	Ibuprofen	Ibuprofen Capsules 200 mg	TIME CAP LABORATORIES, INC.	ANDA	Current
49483-610	IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES, INC	ANDA	Current
49483-610	IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES, INC	ANDA	Current
49483-610	IBUPROFEN	IBUPROFEN	TIME CAP LABORATORIES, INC	ANDA	Current
50844-268	Ibuprofen	Ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-268	Ibuprofen	Ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-268	Ibuprofen	Ibuprofen	L.N.K. International, Inc.	ANDA	Current
50844-268	Ibuprofen	Ibuprofen	L.N.K. International, Inc.	ANDA	Current
55315-940	IBUPROFEN	IBUPROFEN	FRED'S INC.	ANDA	Current
55315-940	IBUPROFEN	IBUPROFEN	FRED'S INC.	ANDA	Current
55910-399	Ibuprofen	Ibuprofen	DOLGENCORP, INC.	ANDA	Current
57344-185	Ibuprofen	Ibuprofen	AAA Pharmaceutical, Inc.	ANDA	Current
59105-002	IBUPROFEN	IBUPROFEN	J.P BUSINESS ENTERPRISE	ANDA	Current
59779-131	CVS Pharmacy Ibuprofen	Ibuprofen	CVS Pharmacy	ANDA	Current
63654-363	Ibuprofen	Ibuprofen 200 mg	Selder, S.A. de C.V.	ANDA	Current
67091-185	Ibuprofen	Ibuprofen	Winco Foods, LLC	ANDA	Current
67091-185	Ibuprofen	Ibuprofen	Winco Foods, LLC	ANDA	Current
68210-0009	IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	ANDA	Current
68210-0009	IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	ANDA	Current
68210-0009	IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	ANDA	Current
68210-0009	IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	ANDA	Current
68210-0009	IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	ANDA	Current
68210-0200	IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	ANDA	Current
68210-0200	IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	ANDA	Current
68210-0200	IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	ANDA	Current
68210-0200	IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	ANDA	Current
68210-0200	IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	ANDA	Current
68210-4141	IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	ANDA	Current
68210-4141	IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	ANDA	Current
68210-4141	IBUPROFEN	IBUPROFEN	SPIRIT PHARMACEUTICALS,LLC	ANDA	Current
68998-185	Ibuprofen	Ibuprofen	MARC GLASSMAN, INC.	ANDA	Current
69168-363	Ibuprofen	Ibuprofen 200 mg	Allegiant Health	ANDA	Current
69168-368	Ibuprofen 200 mg	Ibuprofen	Allegiant Health	ANDA	Current
69168-368	Ibuprofen 200 mg	Ibuprofen	Allegiant Health	ANDA	Current
69168-914	Sound Body Ibuprofen	Ibuprofen 200 mg	Allegiant Health	ANDA	Current
69168-914	Sound Body Ibuprofen	Ibuprofen 200 mg	Allegiant Health	ANDA	Current
69168-914	Sound Body Ibuprofen	Ibuprofen 200 mg	Allegiant Health	ANDA	Current
72036-185	Ibuprofen	Ibuprofen	Harris Teeter	ANDA	Current
81522-185	Ibuprofen	Ibuprofen	FSA STORE INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22635	ORIG	2011-09-19