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 4 of 5 · 92 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MirtazapineMIRTAZAPINENorthStar Rx LLC979eec8b-1bf4-466b-812e-85a111ce1cb52025-02-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEMcKesson Corporation dba SKY Packaging40c95daa-bbd5-48d9-97e4-c87f2c1f0fa52025-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEAmerican Health Packaging3b7a5f44-8da6-4196-bb5d-8d2770af1b3a2025-01-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEAdvanced Rx Pharmacy of Tennessee, LLCf8c383c1-d1b3-ceaa-e053-6294a90a60532024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEBryant Ranch Prepack3bb242b0-42ed-471a-b3c4-5ded1e292e802024-11-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEBryant Ranch Prepackc47428e5-4717-4471-9231-ec8b5438205a2024-11-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLC20eafce1-50cd-0d9c-e063-6394a90ad6fe2024-09-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEBryant Ranch Prepack8c03eb2b-6aed-40a1-a424-67ac1ab6085d2024-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEBryant Ranch Prepackecf7826c-c583-4836-9b00-bf9e4b51a1442024-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLC1e0006b6-9405-95a7-e063-6294a90aa2772024-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEBryant Ranch Prepackded5b83b-f11a-4a6a-bf77-c5fe6dc4c4f52024-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLCac976282-fb68-4db0-912a-28f075b0716c2024-06-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINENuCare Pharmaceuticals,Inc.8e839bb2-2f67-f224-e053-2a95a90ae5d82024-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEGolden State Medical Supply, Inc.a6a5949f-5ebf-f37d-e053-2995a90adae52024-06-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEBryant Ranch Prepack9f0f52e8-3318-4da2-b0d9-ea3d33bfe41e2023-10-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINENCS HealthCare of KY, LLC dba Vangard Labs70439462-b632-4d21-8067-560162db31372023-09-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEBryant Ranch Prepack1ba111d1-cf92-4cd9-afcb-3bebd1bacd462023-08-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINESQUARE PHARMACEUTICALS LIMITED83093852-d212-408e-98fd-33f4603a9d652023-07-02Name fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLCfaba9bfd-6725-4917-ab48-24e58b397eb42023-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mirtazapine
generic name: MIRTAZAPINE
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLC50ccc34a-4b89-4b07-b153-6c71c6924db12023-06-06Boxed 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.