Application 076122

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIRTAZAPINEMIRTAZAPINETABLET;ORAL15MGNoNo
002MIRTAZAPINEMIRTAZAPINETABLET;ORAL30MGNoNo
003MIRTAZAPINEMIRTAZAPINETABLET;ORAL45MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076122-001MIRTAZAPINEMIRTAZAPINE15MGTABLET / ORALAB2003-06-19
A076122-002MIRTAZAPINEMIRTAZAPINE30MGTABLET / ORALAB2003-06-19
A076122-003MIRTAZAPINEMIRTAZAPINE45MGTABLET / ORALAB2003-06-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A076122-001AB
A076122-002AB
A076122-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076122-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076122-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076122-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076122-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076122-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076122-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076122-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076122-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076122-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076122-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076122-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076122-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076122-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076122-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076122-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076122-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076122-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076122-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076122-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076122-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076122-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076122-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076122-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076122-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076122-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076122-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076122-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076122-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A076122-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A076122-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076122-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076122-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076122-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076122-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076122-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076122-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076122-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076122-002MIRTAZAPINE30MGTABLET / ORALAB2003-06-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076122-003MIRTAZAPINE45MGTABLET / ORALAB2003-06-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076122-001MIRTAZAPINE15MGTABLET / ORALAB2003-06-198072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076122-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076122-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076122-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076122-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076122-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076122-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076122-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076122-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076122-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076122-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076122-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076122-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076122-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076122-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076122-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076122-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076122-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076122-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076122-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076122-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076122-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076122-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076122-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076122-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076122-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076122-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076122-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076122-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076122-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076122-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076122-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076122-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076122-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076122-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076122-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076122-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076122-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076122-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076122-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076122-001AB18072bd15b7f6…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MirtazapineMIRTAZAPINECardinal Health 107, LLC7a5545a0-4dbb-48ac-b0d2-477a8dd4b87e2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076122
application number: ANDA076122
MirtazapineMIRTAZAPINESafecor Health LLC6d2ff278-0c80-4373-b77d-b5f186c4b9912026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076122
application number: ANDA076122
MirtazapineMIRTAZAPINEREMEDYREPACK INC.412abf0e-1f96-4d4d-bb56-a23d4699b14c2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076122
application number: ANDA076122
MirtazapineMIRTAZAPINEMylan Institutional Inc.6837b69b-2f86-42cf-b48d-b4a3c7b5413f2025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076122
application number: ANDA076122
ndc (product): 51079-086
ndc (product): 51079-087
ndc (product): 51079-088
MirtazapineMIRTAZAPINECardinal Health 107, LLC89ae6a33-933f-47aa-a2de-2a71cd3f7d442025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076122
application number: ANDA076122
ndc (product): 55154-5355
MirtazapineMIRTAZAPINEGolden State Medical Supply, Inc.a6a5949f-5ebf-f37d-e053-2995a90adae52024-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076122
application number: ANDA076122
ndc (product): 51407-350
ndc (product): 51407-351
ndc (product): 51407-352
MirtazapineMIRTAZAPINEMylan Pharmaceuticals Inc.711aa80b-8fc6-49e6-9494-3db31d9b53a42022-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076122
application number: ANDA076122
ndc (product): 0378-3515
ndc (product): 0378-3545
ndc (product): 0378-3530
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLC500dbfbe-2a00-496d-9e44-6e59d2c68ea22021-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076122
application number: ANDA076122
ndc (product): 71610-523
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLC93c4ddcf-ca4f-4a46-a7b7-1395fb0885d22020-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076122
application number: ANDA076122
ndc (product): 71610-475

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 72 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3515MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3530MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0378-3545MirtazapineMirtazapineMylan Pharmaceuticals Inc.ANDACurrent
0615-5527MirtazapineMirtazapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5572MirtazapineMirtazapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5572MirtazapineMirtazapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5573MirtazapineMirtazapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5573MirtazapineMirtazapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43353-962MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-962MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-963MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-963MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-086MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51079-086MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51079-086MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51079-087MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51079-087MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51079-087MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51079-088MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51079-088MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51079-088MirtazapineMirtazapineMylan Institutional Inc.ANDACurrent
51407-350MirtazapineMirtazapineGolden State Medical SupplyANDACurrent
51407-350MirtazapineMirtazapineGolden State Medical SupplyANDACurrent
51407-350MirtazapineMirtazapineGolden State Medical Supply, Inc.ANDACurrent
51407-350MirtazapineMirtazapineGolden State Medical Supply, Inc.ANDACurrent
51407-351MirtazapineMirtazapineGolden State Medical SupplyANDACurrent
51407-351MirtazapineMirtazapineGolden State Medical SupplyANDACurrent
51407-351MirtazapineMirtazapineGolden State Medical Supply, Inc.ANDACurrent
51407-351MirtazapineMirtazapineGolden State Medical Supply, Inc.ANDACurrent
51407-352MirtazapineMirtazapineGolden State Medical SupplyANDACurrent
51407-352MirtazapineMirtazapineGolden State Medical SupplyANDACurrent
51407-352MirtazapineMirtazapineGolden State Medical Supply, Inc.ANDACurrent
51407-352MirtazapineMirtazapineGolden State Medical Supply, Inc.ANDACurrent
53808-0384MirtazapineMirtazapineState of Florida DOH Central PharmacyANDACurrent
55154-5355MirtazapineMirtazapineCardinal HealthANDACurrent
55154-5355MirtazapineMirtazapineCardinal HealthANDACurrent
55154-5355MirtazapineMirtazapineCardinal HealthANDACurrent
55154-5355MirtazapineMirtazapineCardinal HealthANDACurrent
67046-481MirtazapineMirtazapineContract Pharmacy Services-PAANDACurrent
67046-482MirtazapineMirtazapineContract Pharmacy Services-PAANDACurrent
67046-483MirtazapineMirtazapineContract Pharmacy Services-PAANDACurrent
70518-0102MirtazapineMirtazapineREMEDYREPACK INC.ANDACurrent
70518-0102MirtazapineMirtazapineREMEDYREPACK INC.ANDACurrent
70518-0102MirtazapineMirtazapineREMEDYREPACK INC.ANDACurrent
71610-475MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-523MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-523MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-523MirtazapineMirtazapineAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44287ORIG2005-08-01
43054ORIG2005-07-22
31081ORIG2003-04-10