FDA.reportPublic FDA data

Application 202101

Type
ANDA
Sponsor
ALEMBIC 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
A202101-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28
A202101-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28
A202101-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28
A202101-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28
A202101-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28
A202101-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202101-001AB
A202101-002AB
A202101-003AB
A202101-004AB
A202101-005AB
A202101-006AB

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 UTC2026-02A202101-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202101-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202101-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202101-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202101-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202101-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-282680178bc6a6…

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 UTC2026-02A202101-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202101-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202101-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202101-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202101-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202101-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202101-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202101-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202101-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202101-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202101-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202101-004AB12680178bc6a6…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.119e3387-39a2-4fe5-904b-c2d008425c0a2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202101
application number: ANDA202101
ndc (product): 70518-2281
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.99747897-22fe-4bee-9942-6349c0c8f6b02026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202101
application number: ANDA202101
ndc (product): 70518-2150
AripiprazoleARIPIPRAZOLECoupler LLC56439ef6-a07e-34c9-e063-6294a90a77c32026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202101
application number: ANDA202101
AripiprazoleARIPIPRAZOLECoupler LLC52cc86ba-2c4f-1aba-e063-6294a90a844e2026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202101
application number: ANDA202101
AripiprazoleARIPIPRAZOLECoupler LLC512874e6-6d00-2623-e063-6394a90aa4bc2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202101
application number: ANDA202101
AripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals Inc.02a4af27-c83c-4166-950c-7a1cb12d198d2026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202101
application number: ANDA202101
AripiprazoleARIPIPRAZOLEAlembic Pharmaceuticals Inc.a10a5427-58b1-42dd-964c-3f8c787705342025-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202101
application number: ANDA202101
ndc (product): 62332-101
ndc (product): 62332-102
ndc (product): 62332-097
ndc (product): 62332-099
ndc (product): 62332-100
ndc (product): 62332-098
AripiprazoleARIPIPRAZOLEAlembic Pharmaceuticals Limited793fc904-2f11-4f97-a0ac-4d6910cac0f92023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202101
application number: ANDA202101
ndc (product): 46708-259
ndc (product): 46708-256
ndc (product): 46708-258
ndc (product): 46708-257
ndc (product): 46708-255
ndc (product): 46708-254

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 60 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13811-679AripiprazoleAripiprazoleTrigen Laboratories, LLCANDACurrent
13811-680AripiprazoleAripiprazoleTrigen Laboratories, LLCANDACurrent
13811-681AripiprazoleAripiprazoleTrigen Laboratories, LLCANDACurrent
13811-682AripiprazoleAripiprazoleTrigen Laboratories, LLCANDACurrent
13811-683AripiprazoleAripiprazoleTrigen Laboratories, LLCANDACurrent
13811-684AripiprazoleAripiprazoleTrigen Laboratories, LLCANDACurrent
17856-0680AripiprazoleAripiprazoleAtlantic Biologicals CorpsANDACurrent
17856-0680AripiprazoleAripiprazoleAtlantic Biologicals CorpsANDACurrent
46708-254AripiprazoleAripiprazoleAlembic Pharmaceuticals LimitedANDACurrent
46708-254AripiprazoleAripiprazoleAlembic Pharmaceuticals LimitedANDACurrent
46708-255AripiprazoleAripiprazoleAlembic Pharmaceuticals LimitedANDACurrent
46708-255AripiprazoleAripiprazoleAlembic Pharmaceuticals LimitedANDACurrent
46708-256AripiprazoleAripiprazoleAlembic Pharmaceuticals LimitedANDACurrent
46708-256AripiprazoleAripiprazoleAlembic Pharmaceuticals LimitedANDACurrent
46708-257AripiprazoleAripiprazoleAlembic Pharmaceuticals LimitedANDACurrent
46708-257AripiprazoleAripiprazoleAlembic Pharmaceuticals LimitedANDACurrent
46708-258AripiprazoleAripiprazoleAlembic Pharmaceuticals LimitedANDACurrent
46708-258AripiprazoleAripiprazoleAlembic Pharmaceuticals LimitedANDACurrent
46708-259AripiprazoleAripiprazoleAlembic Pharmaceuticals LimitedANDACurrent
46708-259AripiprazoleAripiprazoleAlembic Pharmaceuticals LimitedANDACurrent
62332-097AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-097AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-097AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-097AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-097AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-098AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-098AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-098AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-098AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-098AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-099AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-099AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-099AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-099AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-099AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-100AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-100AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-100AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-100AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-100AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-101AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-101AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-101AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-101AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-101AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-102AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-102AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-102AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-102AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
62332-102AripiprazoleAripiprazoleAlembic Pharmaceuticals Inc.ANDACurrent
68151-4459AripiprazoleAripiprazoleCarilion Materials ManagementANDACurrent
70518-1794AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1794AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1822AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1822AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1870AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1871AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2149AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2150AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2281AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
40120ORIG2015-04-29
9960ORIG2015-04-29