Application 076541

Type
ANDA
Sponsor
SUN PHARM INDS INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076541-001MIRTAZAPINEMIRTAZAPINE15MGTABLET / ORALAB2004-04-22
A076541-002MIRTAZAPINEMIRTAZAPINE30MGTABLET / ORALAB2004-04-22
A076541-003MIRTAZAPINEMIRTAZAPINE45MGTABLET / ORALAB2004-04-22
A076541-004MIRTAZAPINEMIRTAZAPINE7.5MGTABLET / ORALABRS2004-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076541-001AB
A076541-002AB
A076541-003AB
A076541-004AB

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.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076541-001MIRTAZAPINE15MGTABLET / ORALAB2004-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A076541-002MIRTAZAPINE30MGTABLET / ORALAB2004-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A076541-003MIRTAZAPINE45MGTABLET / ORALAB2004-04-22caaa826d4ba7…
2026-08-18 06:07:402026-07A076541-004MIRTAZAPINE7.5MGTABLET / ORALABRS2004-04-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076541-001MIRTAZAPINE15MGTABLET / ORALAB2004-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076541-002MIRTAZAPINE30MGTABLET / ORALAB2004-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076541-003MIRTAZAPINE45MGTABLET / ORALAB2004-04-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076541-004MIRTAZAPINE7.5MGTABLET / ORALABRS2004-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076541-001MIRTAZAPINE15MGTABLET / ORALAB2004-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076541-002MIRTAZAPINE30MGTABLET / ORALAB2004-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076541-003MIRTAZAPINE45MGTABLET / ORALAB2004-04-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076541-004MIRTAZAPINE7.5MGTABLET / ORALABRS2004-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A076541-001MIRTAZAPINE15MGTABLET / ORALAB2004-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076541-002MIRTAZAPINE30MGTABLET / ORALAB2004-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076541-003MIRTAZAPINE45MGTABLET / ORALAB2004-04-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076541-004MIRTAZAPINE7.5MGTABLET / ORALABRS2004-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076541-001MIRTAZAPINE15MGTABLET / ORALAB2004-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076541-002MIRTAZAPINE30MGTABLET / ORALAB2004-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076541-003MIRTAZAPINE45MGTABLET / ORALAB2004-04-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076541-004MIRTAZAPINE7.5MGTABLET / ORALABRS2004-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076541-001MIRTAZAPINE15MGTABLET / ORALAB2004-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076541-002MIRTAZAPINE30MGTABLET / ORALAB2004-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076541-003MIRTAZAPINE45MGTABLET / ORALAB2004-04-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076541-004MIRTAZAPINE7.5MGTABLET / ORALABRS2004-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076541-001MIRTAZAPINE15MGTABLET / ORALAB2004-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076541-002MIRTAZAPINE30MGTABLET / ORALAB2004-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076541-003MIRTAZAPINE45MGTABLET / ORALAB2004-04-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076541-004MIRTAZAPINE7.5MGTABLET / ORALABRS2004-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076541-001MIRTAZAPINE15MGTABLET / ORALAB2004-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076541-002MIRTAZAPINE30MGTABLET / ORALAB2004-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076541-003MIRTAZAPINE45MGTABLET / ORALAB2004-04-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076541-004MIRTAZAPINE7.5MGTABLET / ORALABRS2004-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076541-001MIRTAZAPINE15MGTABLET / ORALAB2004-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076541-002MIRTAZAPINE30MGTABLET / ORALAB2004-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076541-003MIRTAZAPINE45MGTABLET / ORALAB2004-04-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076541-004MIRTAZAPINE7.5MGTABLET / ORALABRS2004-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076541-001MIRTAZAPINE15MGTABLET / ORALAB2004-04-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076541-002MIRTAZAPINE30MGTABLET / ORALAB2004-04-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076541-003MIRTAZAPINE45MGTABLET / ORALAB2004-04-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076541-004MIRTAZAPINE7.5MGTABLET / ORALABRS2004-04-22d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076541-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076541-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076541-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076541-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076541-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076541-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076541-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076541-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076541-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076541-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076541-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076541-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076541-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076541-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076541-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076541-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076541-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076541-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076541-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076541-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076541-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076541-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076541-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076541-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076541-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076541-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076541-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076541-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076541-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076541-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076541-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076541-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076541-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076541-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076541-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076541-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076541-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076541-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076541-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076541-004AB1d8e5a09893c0…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MirtazapineMIRTAZAPINEBryant Ranch Prepack577c3ceb-316b-4c93-9b0c-0a4b1b4773e92026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076541
application number: ANDA076541
ndc (product): 71335-0441
MirtazapineMIRTAZAPINEREMEDYREPACK INC.e708e8bb-9b13-44d9-96f5-fd73a893a9872026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076541
application number: ANDA076541
MirtazapineMIRTAZAPINEBryant Ranch Prepack356eb045-6347-49cc-818e-65b1cdff8f4e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076541
application number: ANDA076541
MirtazapineMIRTAZAPINEAvKAREe5478a6a-a29a-9f61-e053-2995a90a11d02025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076541
application number: ANDA076541
ndc (product): 42291-494
MirtazapineMIRTAZAPINEBryant Ranch Prepack3bb242b0-42ed-471a-b3c4-5ded1e292e802024-11-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076541
application number: ANDA076541
ndc (product): 63629-2368
MirtazapineMIRTAZAPINEBryant Ranch Prepack8c03eb2b-6aed-40a1-a424-67ac1ab6085d2024-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076541
application number: ANDA076541
ndc (product): 63629-2366
MirtazapineMIRTAZAPINEBryant Ranch Prepackecf7826c-c583-4836-9b00-bf9e4b51a1442024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076541
application number: ANDA076541
ndc (product): 63629-2367
MirtazapineMIRTAZAPINEBryant Ranch Prepackded5b83b-f11a-4a6a-bf77-c5fe6dc4c4f52024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076541
application number: ANDA076541
MirtazapineMIRTAZAPINEBryant Ranch Prepack9f0f52e8-3318-4da2-b0d9-ea3d33bfe41e2023-10-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076541
application number: ANDA076541
ndc (product): 71335-0286
MirtazapineMIRTAZAPINEBryant Ranch Prepack1ba111d1-cf92-4cd9-afcb-3bebd1bacd462023-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076541
application number: ANDA076541
MirtazapineMIRTAZAPINEAphena Pharma Solutions - Tennessee, LLC50ccc34a-4b89-4b07-b153-6c71c6924db12023-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076541
application number: ANDA076541
MirtazapineMIRTAZAPINESun Pharmaceutical Industries, Inc.f23631be-c7ae-46e9-b771-a70be17bc9f02021-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076541
application number: ANDA076541
ndc (product): 57664-499
ndc (product): 57664-501
ndc (product): 57664-500
ndc (product): 57664-510

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 67 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8078MirtazapineMirtazapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8078MirtazapineMirtazapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
16714-706MirtazapineMirtazapineNorthstar Rx LLCANDACurrent
16714-706MirtazapineMirtazapineNorthstar Rx LLCANDACurrent
16714-706MirtazapineMirtazapineNorthstar Rx LLCANDACurrent
16714-707MirtazapineMirtazapineNorthstar Rx LLCANDACurrent
16714-707MirtazapineMirtazapineNorthstar Rx LLCANDACurrent
16714-707MirtazapineMirtazapineNorthstar Rx LLCANDACurrent
16714-708MirtazapineMirtazapineNorthstar Rx LLCANDACurrent
16714-708MirtazapineMirtazapineNorthstar Rx LLCANDACurrent
16714-708MirtazapineMirtazapineNorthstar Rx LLCANDACurrent
16714-709MirtazapineMirtazapineNorthstar Rx LLCANDACurrent
16714-709MirtazapineMirtazapineNorthstar Rx LLCANDACurrent
16714-709MirtazapineMirtazapineNorthstar Rx LLCANDACurrent
42291-494MirtazapineMirtazapineAvKAREANDACurrent
50090-5296MirtazapineMirtazapineA-S Medication SolutionsANDACurrent
53808-0735MirtazapineMIRTAZAPINEState of Florida DOH Central PharmacyANDACurrent
53808-0736MirtazapineMIRTAZAPINEState of Florida DOH Central PharmacyANDACurrent
53808-0737MirtazapineMIRTAZAPINEState of Florida DOH Central PharmacyANDACurrent
57664-499MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-499MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-499MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-499MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-499MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-499MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-500MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-500MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-500MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-500MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-500MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-500MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-501MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-501MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-501MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-501MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-501MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-501MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-510MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-510MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-510MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-510MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-510MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
57664-510MirtazapineMirtazapineSun Pharmaceutical Industries, Inc.ANDACurrent
63629-2366MirtazapineMirtazapineBryant Ranch PrepackANDACurrent
63629-2366MirtazapineMirtazapineBryant Ranch PrepackANDACurrent
63629-2366MirtazapineMirtazapineBryant Ranch PrepackANDACurrent
63629-2367MirtazapineMirtazapineBryant Ranch PrepackANDACurrent
63629-2367MirtazapineMirtazapineBryant Ranch PrepackANDACurrent
63629-2367MirtazapineMirtazapineBryant Ranch PrepackANDACurrent
63629-2368MirtazapineMirtazapineBryant Ranch PrepackANDACurrent
63629-2368MirtazapineMirtazapineBryant Ranch PrepackANDACurrent
63629-2368MirtazapineMirtazapineBryant Ranch PrepackANDACurrent
68071-1659MirtazapineMirtazapineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1716MirtazapineMirtazapineNuCare Pharmaceuticals,Inc.ANDACurrent
70518-1583MirtazapineMirtazapineREMEDYREPACK INC.ANDACurrent
70518-1583MirtazapineMirtazapineREMEDYREPACK INC.ANDACurrent
70518-2582MirtazapineMirtazapineREMEDYREPACK INC.ANDACurrent
70518-2582MirtazapineMirtazapineREMEDYREPACK INC.ANDACurrent
70518-2582MirtazapineMirtazapineREMEDYREPACK INC.ANDACurrent
71335-0286MirtazapineMirtazapineBryant Ranch PrepackANDACurrent
71335-0286MirtazapineMirtazapineBryant Ranch PrepackANDACurrent
71335-0286MirtazapineMirtazapineBryant Ranch PrepackANDACurrent
71335-0441MirtazapineMirtazapineBryant Ranch PrepackANDACurrent
71335-0441MirtazapineMirtazapineBryant Ranch PrepackANDACurrent
71335-0441MirtazapineMirtazapineBryant Ranch PrepackANDACurrent
71335-0532MirtazapineMirtazapineBryant Ranch PrepackANDACurrent
71335-0532MirtazapineMirtazapineBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23831ORIG2005-08-01