FDA.reportPublic FDA data

Application 206383

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL2MGNoNo
002ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL5MGNoNo
003ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL10MGNoNo
004ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL15MGNoNo
005ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL20MGNoNo
006ARIPIPRAZOLEARIPIPRAZOLETABLET;ORAL30MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206383-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2016-09-29
A206383-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2016-09-29
A206383-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2016-09-29
A206383-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2016-09-29
A206383-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2016-09-29
A206383-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORALAB2016-09-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A206383-001AB
A206383-002AB
A206383-003AB
A206383-004AB
A206383-005AB
A206383-006AB

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206383-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206383-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206383-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206383-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206383-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206383-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206383-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206383-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206383-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206383-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206383-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206383-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A206383-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206383-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206383-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206383-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206383-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206383-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206383-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206383-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206383-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206383-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206383-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206383-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206383-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206383-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206383-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206383-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206383-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206383-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206383-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206383-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206383-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206383-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206383-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206383-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206383-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206383-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206383-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206383-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-09-292680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206383-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206383-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206383-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206383-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206383-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206383-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206383-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206383-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206383-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206383-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206383-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206383-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206383-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206383-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206383-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206383-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206383-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206383-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206383-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206383-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206383-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206383-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206383-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206383-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206383-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206383-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206383-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206383-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206383-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206383-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206383-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206383-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206383-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206383-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206383-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206383-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206383-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206383-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206383-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206383-004AB12680178bc6a6…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEDr.Reddys Laboratories Inc178f09f0-e08e-452b-b817-717c5c49e1102025-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206383
application number: ANDA206383
ndc (product): 43598-967
ndc (product): 43598-966
ndc (product): 43598-968
ndc (product): 43598-970
ndc (product): 43598-969
ndc (product): 43598-965
AripiprazoleARIPIPRAZOLENCS HealthCare of KY, LLC dba Vangard Labsd8183eaf-0093-4720-b8ed-20e5706975112024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206383
application number: ANDA206383
AripiprazoleARIPIPRAZOLEScieGen Pharmaceuticals Inca7d9d5d1-25ba-4f4e-a990-398c0bf09c7e2023-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206383
application number: ANDA206383
ndc (product): 50228-478
ndc (product): 50228-477
ndc (product): 50228-476
ndc (product): 50228-475
ndc (product): 50228-480
ndc (product): 50228-479
AripiprazoleARIPIPRAZOLENCS HealthCare of KY, LLC dba Vangard Labs8da99c93-613e-4b78-9f91-3efc2dea194d2022-08-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206383
application number: ANDA206383
ndc (product): 0615-8375
AripiprazoleARIPIPRAZOLEDr.Reddys Laboratories Inc0aa7e178-456a-4942-93aa-9ec18a58939f2020-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206383
application number: ANDA206383
ndc (product): 43598-556
ndc (product): 43598-555
ndc (product): 43598-558
ndc (product): 43598-557
ndc (product): 43598-554
ndc (product): 43598-559
AripiprazoleARIPIPRAZOLEScieGen Pharmaceuticals Inc95954ba3-e838-4dd7-aef1-c51ac6aff76b2020-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206383
application number: ANDA206383
ndc (product): 50228-324
ndc (product): 50228-329
ndc (product): 50228-328
ndc (product): 50228-327
ndc (product): 50228-326
ndc (product): 50228-325

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 65 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8259AripiprazoleAripiprazoleNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8259AripiprazoleAripiprazoleNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8375AripiprazoleAripiprazoleNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8375AripiprazoleAripiprazoleNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
43598-554AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-554AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-554AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-554AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-555AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-555AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-555AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-555AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-556AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-556AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-556AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-556AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-557AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-557AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-557AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-557AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-558AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-558AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-558AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-558AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-559AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-559AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-559AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-559AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-965AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-966AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-967AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-968AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-969AripiprazoleAripiprazoleDr.ReddyANDACurrent
43598-970AripiprazoleAripiprazoleDr.ReddyANDACurrent
50090-2824AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50228-324AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-324AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-324AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-325AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-325AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-325AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-326AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-326AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-326AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-327AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-327AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-327AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-328AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-328AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-328AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-329AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-329AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-329AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-475AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-476AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-477AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-478AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-479AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
50228-480AripiprazoleAripiprazoleScieGen Pharmaceuticals IncANDACurrent
70518-0675AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0675AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0884AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0884AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1065AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1065AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent