Application 018006

Type: NDA
Sponsor: PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MECLOMEN	MECLOFENAMATE SODIUM	CAPSULE;ORAL	EQ 50MG BASE	No	No
002	MECLOMEN	MECLOFENAMATE SODIUM	CAPSULE;ORAL	EQ 100MG BASE	No	No

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

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
N018006-001	MECLOMEN	MECLOFENAMATE SODIUM	EQ 50MG BASE	CAPSULE / ORAL		Approved before 1982
N018006-002	MECLOMEN	MECLOFENAMATE SODIUM	EQ 100MG BASE	CAPSULE / ORAL		Approved before 1982

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N018006-001	MECLOMEN	EQ 50MG BASE	CAPSULE / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N018006-002	MECLOMEN	EQ 100MG BASE	CAPSULE / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018006-001	MECLOMEN	EQ 50MG BASE	CAPSULE / ORAL	Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N018006-002	MECLOMEN	EQ 100MG BASE	CAPSULE / ORAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018006-001	MECLOMEN	EQ 50MG BASE	CAPSULE / ORAL	Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018006-002	MECLOMEN	EQ 100MG BASE	CAPSULE / ORAL	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018006-001	MECLOMEN	EQ 50MG BASE	CAPSULE / ORAL	Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018006-002	MECLOMEN	EQ 100MG BASE	CAPSULE / ORAL	Approved before 1982	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meclofenamate Sodium	MECLOFENAMATE SODIUM	Mylan Pharmaceuticals Inc.	96f19af4-de8f-4fd7-90d8-55fe6ebdd81d	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MECLOFENAMATE SODIUM

Reported adverse events (FAERS/openFDA)#

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