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 43.

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
2026-09-14 22:38:342026-08A220104-001MIRTAZAPINE7.5MGTABLET / ORALAB2026-05-1984e616aacf4f…
2026-09-14 22:38:342026-08A220104-002MIRTAZAPINE15MGTABLET / ORALAB2026-05-1984e616aacf4f…
2026-09-14 22:38:342026-08A220104-003MIRTAZAPINE30MGTABLET / ORALAB2026-05-1984e616aacf4f…
2026-09-14 22:38:342026-08A220104-004MIRTAZAPINE45MGTABLET / ORALAB2026-05-1984e616aacf4f…
2026-08-18 06:07:402026-07A220104-001MIRTAZAPINE7.5MGTABLET / ORALAB2026-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07A220104-002MIRTAZAPINE15MGTABLET / ORALAB2026-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07A220104-003MIRTAZAPINE30MGTABLET / ORALAB2026-05-19caaa826d4ba7…
2026-08-18 06:07:402026-07A220104-004MIRTAZAPINE45MGTABLET / ORALAB2026-05-19caaa826d4ba7…
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
2026-09-14 22:38:342026-08A220104-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A220104-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A220104-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A220104-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A220104-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A220104-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A220104-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A220104-004AB1caaa826d4ba7…
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 2 of 5 · 92 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
MirtazapineMIRTAZAPINEREMEDYREPACK INC.1b13d7ec-ecdc-482c-8fe2-b999bab3bbeb2026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEREMEDYREPACK INC.f54718d1-3ef7-4472-9e97-90e5fd30db4d2026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEBryant Ranch Prepack6b6e946c-54b5-40e3-918f-9cc29f04cd9a2026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEREMEDYREPACK INC.81d9e47e-ae81-4755-a5ee-546a038fadb42026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEBryant Ranch Prepack7727fe84-f6cc-4b31-bc00-1ecf741ad3612026-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEREMEDYREPACK INC.e708e8bb-9b13-44d9-96f5-fd73a893a9872026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEA-S Medication Solutions44779383-3ddb-41df-8766-da5d7bef385e2026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEDirect_Rxdea8c09a-b759-1da7-e053-2a95a90a33462026-01-08Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEREMEDYREPACK INC.d1b59d87-8442-4c15-8bb9-e39b198d86772026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEBryant Ranch Prepackc2b38cc5-7738-44fa-9bef-89a18a1039b22025-12-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEBryant Ranch Prepack1cc1a159-11ec-4040-817b-d57fa827a7732025-11-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEBryant Ranch Prepack1fb26f9b-b075-471d-8cc3-fa39246ec2e42025-11-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEBryant Ranch Prepackbeaa0678-e4b9-4241-8b08-e69e2e49530f2025-11-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEBryant Ranch Prepackbd532a25-cfde-4c7d-8015-ba40609fb95c2025-11-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE

Reported adverse events (FAERS/openFDA)#

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