FDA.reportPublic FDA data

Application 017543

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUDIOMILMAPROTILINE HYDROCHLORIDETABLET;ORAL25MGNoNo
002LUDIOMILMAPROTILINE HYDROCHLORIDETABLET;ORAL50MGNoNo
003LUDIOMILMAPROTILINE HYDROCHLORIDETABLET;ORAL75MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017543-001LUDIOMILMAPROTILINE HYDROCHLORIDE25MGTABLET / ORALApproved before 1982
N017543-002LUDIOMILMAPROTILINE HYDROCHLORIDE50MGTABLET / ORALApproved before 1982
N017543-003LUDIOMILMAPROTILINE HYDROCHLORIDE75MGTABLET / ORAL1982-09-30

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 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N017543-001LUDIOMIL25MGTABLET / ORALApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N017543-002LUDIOMIL50MGTABLET / ORALApproved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N017543-003LUDIOMIL75MGTABLET / ORAL1982-09-3084e616aacf4f…
2026-08-18 06:07:402026-07N017543-001LUDIOMIL25MGTABLET / ORALApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017543-002LUDIOMIL50MGTABLET / ORALApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017543-003LUDIOMIL75MGTABLET / ORAL1982-09-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017543-001LUDIOMIL25MGTABLET / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017543-002LUDIOMIL50MGTABLET / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017543-003LUDIOMIL75MGTABLET / ORAL1982-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017543-001LUDIOMIL25MGTABLET / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017543-002LUDIOMIL50MGTABLET / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017543-003LUDIOMIL75MGTABLET / ORAL1982-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N017543-001LUDIOMIL25MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017543-002LUDIOMIL50MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017543-003LUDIOMIL75MGTABLET / ORAL1982-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017543-001LUDIOMIL25MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017543-002LUDIOMIL50MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017543-003LUDIOMIL75MGTABLET / ORAL1982-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017543-001LUDIOMIL25MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017543-002LUDIOMIL50MGTABLET / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017543-003LUDIOMIL75MGTABLET / ORAL1982-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017543-001LUDIOMIL25MGTABLET / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017543-002LUDIOMIL50MGTABLET / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017543-003LUDIOMIL75MGTABLET / ORAL1982-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017543-001LUDIOMIL25MGTABLET / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017543-002LUDIOMIL50MGTABLET / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017543-003LUDIOMIL75MGTABLET / ORAL1982-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017543-001LUDIOMIL25MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017543-002LUDIOMIL50MGTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017543-003LUDIOMIL75MGTABLET / ORAL1982-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017543-001LUDIOMIL25MGTABLET / ORALApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017543-002LUDIOMIL50MGTABLET / ORALApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017543-003LUDIOMIL75MGTABLET / ORAL1982-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017543-001LUDIOMIL25MGTABLET / ORALApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017543-002LUDIOMIL50MGTABLET / ORALApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017543-003LUDIOMIL75MGTABLET / ORAL1982-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017543-001LUDIOMIL25MGTABLET / ORALApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017543-002LUDIOMIL50MGTABLET / ORALApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017543-003LUDIOMIL75MGTABLET / ORAL1982-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017543-001LUDIOMIL25MGTABLET / ORALApproved before 1982301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44012ORIG2007-05-09