Application 075679

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOPROFEN	KETOPROFEN	CAPSULE, EXTENDED RELEASE;ORAL	200MG	No	Yes
002	KETOPROFEN	KETOPROFEN	CAPSULE, EXTENDED RELEASE;ORAL	150MG	No	No
003	KETOPROFEN	KETOPROFEN	CAPSULE, EXTENDED RELEASE;ORAL	100MG	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	RLD / RS	Approval date
A075679-001	KETOPROFEN	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20
A075679-002	KETOPROFEN	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20
A075679-003	KETOPROFEN	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075679-002	KETOPROFEN	150MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075679-003	KETOPROFEN	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2002-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075679-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	RS	2002-02-20	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoprofen	KETOPROFEN	Mylan Pharmaceuticals Inc.	198a4140-f4c0-4478-9157-ee1d68d0bb96	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075679 application number: ANDA075679 ndc (product): 0378-8200

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-8200	Ketoprofen	ketoprofen	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8200	Ketoprofen	ketoprofen	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8200	Ketoprofen	ketoprofen	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8200	Ketoprofen	ketoprofen	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8200	Ketoprofen	ketoprofen	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8200	Ketoprofen	ketoprofen	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8200	Ketoprofen	ketoprofen	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8762	ORIG	2003-04-10