FDA.reportPublic FDA data

Application 219919

Type
ANDA
Sponsor
NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIRTAZAPINEMIRTAZAPINETABLET;ORAL7.5MGNoNo
002MIRTAZAPINEMIRTAZAPINETABLET;ORAL15MGNoNo
003MIRTAZAPINEMIRTAZAPINETABLET;ORAL30MGNoNo
004MIRTAZAPINEMIRTAZAPINETABLET;ORAL45MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219919-001MIRTAZAPINEMIRTAZAPINE7.5MGTABLET / ORALAB2026-02-02
A219919-002MIRTAZAPINEMIRTAZAPINE15MGTABLET / ORALAB2026-02-02
A219919-003MIRTAZAPINEMIRTAZAPINE30MGTABLET / ORALAB2026-02-02
A219919-004MIRTAZAPINEMIRTAZAPINE45MGTABLET / ORALAB2026-02-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A219919-001AB
A219919-002AB
A219919-003AB
A219919-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A219919-001MIRTAZAPINE7.5MGTABLET / ORALAB2026-02-02c2088c7a36db…
2026-10-15 13:18:302026-09A219919-002MIRTAZAPINE15MGTABLET / ORALAB2026-02-02c2088c7a36db…
2026-10-15 13:18:302026-09A219919-003MIRTAZAPINE30MGTABLET / ORALAB2026-02-02c2088c7a36db…
2026-10-15 13:18:302026-09A219919-004MIRTAZAPINE45MGTABLET / ORALAB2026-02-02c2088c7a36db…
2026-09-14 22:38:342026-08A219919-001MIRTAZAPINE7.5MGTABLET / ORALAB2026-02-0284e616aacf4f…
2026-09-14 22:38:342026-08A219919-002MIRTAZAPINE15MGTABLET / ORALAB2026-02-0284e616aacf4f…
2026-09-14 22:38:342026-08A219919-003MIRTAZAPINE30MGTABLET / ORALAB2026-02-0284e616aacf4f…
2026-09-14 22:38:342026-08A219919-004MIRTAZAPINE45MGTABLET / ORALAB2026-02-0284e616aacf4f…
2026-08-18 06:07:402026-07A219919-001MIRTAZAPINE7.5MGTABLET / ORALAB2026-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07A219919-002MIRTAZAPINE15MGTABLET / ORALAB2026-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07A219919-003MIRTAZAPINE30MGTABLET / ORALAB2026-02-02caaa826d4ba7…
2026-08-18 06:07:402026-07A219919-004MIRTAZAPINE45MGTABLET / ORALAB2026-02-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219919-001MIRTAZAPINE7.5MGTABLET / ORALAB2026-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219919-002MIRTAZAPINE15MGTABLET / ORALAB2026-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219919-003MIRTAZAPINE30MGTABLET / ORALAB2026-02-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219919-004MIRTAZAPINE45MGTABLET / ORALAB2026-02-02011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219919-001MIRTAZAPINE7.5MGTABLET / ORALAB2026-02-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219919-002MIRTAZAPINE15MGTABLET / ORALAB2026-02-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219919-003MIRTAZAPINE30MGTABLET / ORALAB2026-02-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219919-004MIRTAZAPINE45MGTABLET / ORALAB2026-02-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A219919-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A219919-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A219919-003AB1c2088c7a36db…
2026-10-15 13:18:302026-09A219919-004AB1c2088c7a36db…
2026-09-14 22:38:342026-08A219919-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A219919-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A219919-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A219919-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A219919-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219919-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219919-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219919-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219919-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219919-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219919-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219919-004AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219919-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219919-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219919-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219919-004AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MirtazapineMIRTAZAPINENCS HealthCare of KY, LLC dba Vangard Labs63f140c2-2a18-4dea-96fe-2658dda28a0c2026-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219919
application number: ANDA219919
MirtazapineMIRTAZAPINEANI Pharmaceuticals, Inc.bb134141-6069-4b86-abac-7783bf5df60d2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219919
application number: ANDA219919

Reported adverse events (FAERS/openFDA)#

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