FDA.reportPublic FDA data

Application 204111

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

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
A204111-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2016-10-07
A204111-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2016-10-07
A204111-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2016-10-07
A204111-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2016-10-07
A204111-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2016-10-07
A204111-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORALAB2016-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204111-001AB
A204111-002AB
A204111-003AB
A204111-004AB
A204111-005AB
A204111-006AB

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 UTC2026-02A204111-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204111-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204111-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204111-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204111-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204111-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-10-072680178bc6a6…

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 UTC2026-02A204111-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204111-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204111-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204111-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204111-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204111-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204111-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204111-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204111-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204111-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204111-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204111-004AB12680178bc6a6…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEMacleods Pharmaceuticals Limitedab4245a1-71f7-45be-a2ef-b0636ed3cc202025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204111
application number: ANDA204111
ndc (product): 33342-124
ndc (product): 33342-123
ndc (product): 33342-127
ndc (product): 33342-126
ndc (product): 33342-125
ndc (product): 33342-122

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 59 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-783AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-783AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-783AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-783AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-784AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-784AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-784AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-784AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-785AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-785AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-785AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-785AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-785AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-786AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-786AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-786AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-786AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-787AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-787AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-787AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-787AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-788AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-788AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-788AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
16714-788AripiprazoleAripiprazoleNorthStar RxLLCANDACurrent
33342-122AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-122AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-122AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-122AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-122AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-123AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-123AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-123AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-123AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-123AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-124AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-124AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-124AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-124AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-124AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-125AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-125AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-125AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-125AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-125AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-126AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-126AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-126AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-126AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-126AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-127AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-127AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-127AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-127AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
33342-127AripiprazoleAripiprazoleMacleods Pharmaceuticals LimitedANDACurrent
50090-4381AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50090-4817AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50090-4817AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
70518-2471AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent