Application 074035

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	KETOPROFEN	KETOPROFEN	CAPSULE;ORAL	50MG	No	No
003	KETOPROFEN	KETOPROFEN	CAPSULE;ORAL	75MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074035-002	KETOPROFEN	KETOPROFEN	50MG	CAPSULE / ORAL			1996-12-31
A074035-003	KETOPROFEN	KETOPROFEN	75MG	CAPSULE / ORAL			1996-12-31

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074035-002	KETOPROFEN	50MG	CAPSULE / ORAL	1996-12-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074035-003	KETOPROFEN	75MG	CAPSULE / ORAL	1996-12-31	`782e0a99824c…`

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
Ketoprofen	KETOPROFEN	Marnel Pharmaceuticals, Inc.	4e7bceb6-dcb5-c5e0-e063-6294a90a101e	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketoprofen generic name: KETOPROFEN
Ketoprofen	KETOPROFEN	Oncora Pharma, LLC	492de5dc-7c1b-47be-8510-43be4e1fd4ed	2026-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketoprofen generic name: KETOPROFEN
Ketoprofen	KETOPROFEN	Misemer Pharmaceuticals, Inc.	d0f47ab6-29ff-df07-e053-2a95a90a2b51	2026-02-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketoprofen generic name: KETOPROFEN
Orudis	KETOPROFEN	Allegis Pharmaceuticals, Inc.	47d0b808-7142-c7a9-e063-6394a90a6e0d	2026-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: KETOPROFEN
Ketoprofen	KETOPROFEN	Mylan Pharmaceuticals Inc.	198a4140-f4c0-4478-9157-ee1d68d0bb96	2024-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketoprofen generic name: KETOPROFEN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-340	Ketoprofen	ketoprofen	Rebel Distributors Corp	ANDA	Current
21695-341	Ketoprofen	ketoprofen	Rebel Distributors Corp	ANDA	Current