Application 017543

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LUDIOMIL	MAPROTILINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
002	LUDIOMIL	MAPROTILINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No
003	LUDIOMIL	MAPROTILINE HYDROCHLORIDE	TABLET;ORAL	75MG	No	No

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

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
N017543-001	LUDIOMIL	MAPROTILINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982
N017543-002	LUDIOMIL	MAPROTILINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982
N017543-003	LUDIOMIL	MAPROTILINE HYDROCHLORIDE	75MG	TABLET / ORAL		1982-09-30

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N017543-001	LUDIOMIL	25MG	TABLET / ORAL	Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N017543-002	LUDIOMIL	50MG	TABLET / ORAL	Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N017543-003	LUDIOMIL	75MG	TABLET / ORAL		1982-09-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017543-001	LUDIOMIL	25MG	TABLET / ORAL	Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N017543-002	LUDIOMIL	50MG	TABLET / ORAL	Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N017543-003	LUDIOMIL	75MG	TABLET / ORAL		1982-09-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017543-001	LUDIOMIL	25MG	TABLET / ORAL	Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017543-002	LUDIOMIL	50MG	TABLET / ORAL	Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017543-003	LUDIOMIL	75MG	TABLET / ORAL		1982-09-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017543-001	LUDIOMIL	25MG	TABLET / ORAL	Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017543-002	LUDIOMIL	50MG	TABLET / ORAL	Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017543-003	LUDIOMIL	75MG	TABLET / ORAL		1982-09-30	`a50c72e98297…`

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
44012	ORIG	2007-05-09