Application 074879

Type: ANDA
Sponsor: ALKERMES GAINESVILLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOPROFEN	KETOPROFEN	CAPSULE, EXTENDED RELEASE;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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074879-001	KETOPROFEN	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL			1997-12-10

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A074879-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	1997-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074879-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	1997-12-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074879-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	1997-12-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074879-001	KETOPROFEN	200MG	CAPSULE, EXTENDED RELEASE / ORAL	1997-12-10	`a50c72e98297…`

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

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42892	ORIG	2003-08-04