FDA.reportPublic FDA data

Application 220104

Type
ANDA
Sponsor
MICRO LABS

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 1.

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
A220104-001MIRTAZAPINEMIRTAZAPINE7.5MGTABLET / ORALAB2026-05-19
A220104-002MIRTAZAPINEMIRTAZAPINE15MGTABLET / ORALAB2026-05-19
A220104-003MIRTAZAPINEMIRTAZAPINE30MGTABLET / ORALAB2026-05-19
A220104-004MIRTAZAPINEMIRTAZAPINE45MGTABLET / ORALAB2026-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A220104-001AB
A220104-002AB
A220104-003AB
A220104-004AB

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220104-001MIRTAZAPINE7.5MGTABLET / ORALAB2026-05-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220104-002MIRTAZAPINE15MGTABLET / ORALAB2026-05-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220104-003MIRTAZAPINE30MGTABLET / ORALAB2026-05-19a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220104-004MIRTAZAPINE45MGTABLET / ORALAB2026-05-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220104-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220104-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220104-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220104-004AB1a50c72e98297…

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 5 · 90 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MirtazapineMIRTAZAPINEREMEDYREPACK INC.10ea9d83-19c3-4f3b-a1cc-cfc48b42507f2026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
mirtazapineMIRTAZAPINEXLCare Pharmaceuticals Inc.b6b31703-e77d-4d1a-b1ac-da972117e3562026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: mirtazapine
generic name: MIRTAZAPINE
mirtazapineMIRTAZAPINEA-S Medication Solutions222dfdde-6979-4b18-a7eb-ff1ad0a437c12026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEBryant Ranch Prepack577c3ceb-316b-4c93-9b0c-0a4b1b4773e92026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEREMEDYREPACK INC.9135e7db-cba4-4150-a69c-fdf2a347a7852026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEPreferred Pharmaceuticals Inc.c22c4325-4f1a-4d12-8039-d3b1263fa3ad2026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEPreferred Pharmaceuticals Inc.ac3716fd-6971-4a70-ae7b-9f5117f3d8802026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEPreferred Pharmaceuticals Inc.2a0689ae-5650-42d1-ac9d-56dd2b4677272026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINECardinal Health 107, LLC7a5545a0-4dbb-48ac-b0d2-477a8dd4b87e2026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEREMEDYREPACK INC.aae4c58a-5cbd-45ef-b0f9-32bf28204f152026-07-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEAmerican Health Packaging82a615a0-e74a-49cb-9a57-ffbb3df604d52026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEUnit Dose Solutions, Inc.5539fe37-546b-40a8-e063-6394a90ace1b2026-06-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINECoupler LLC538679a1-d474-8e1c-e063-6394a90a15d72026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINECoupler LLC53311d08-9dfa-7bb1-e063-6394a90a66562026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEANI Pharmaceuticals, Inc.bb134141-6069-4b86-abac-7783bf5df60d2026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINECoupler LLC51269807-2b5a-e7aa-e063-6394a90ab6572026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINECoupler LLC50718832-88fb-dec1-e063-6294a90ae4682026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
mirtazapineMIRTAZAPINECamber Pharmaceuticals, Inc.b4b9b66e-87a1-4dbb-9eaf-71221bcb22652026-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINESafecor Health LLC6d2ff278-0c80-4373-b77d-b5f186c4b9912026-03-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEA-S Medication Solutions552e2261-53db-4a27-b277-f7b62c3ea2ed2026-02-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE