FDA.reportPublic FDA data

Application 207105

Type
ANDA
Sponsor
ALKEM LABS 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 43.

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
A207105-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2019-02-21
A207105-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2019-02-21
A207105-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2019-02-21
A207105-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2019-02-21
A207105-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2019-02-21
A207105-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORALAB2019-02-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207105-001AB
A207105-002AB
A207105-003AB
A207105-004AB
A207105-005AB
A207105-006AB

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 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207105-001ARIPIPRAZOLE2MGTABLET / ORALAB2019-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A207105-002ARIPIPRAZOLE5MGTABLET / ORALAB2019-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A207105-003ARIPIPRAZOLE10MGTABLET / ORALAB2019-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A207105-004ARIPIPRAZOLE15MGTABLET / ORALAB2019-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A207105-005ARIPIPRAZOLE20MGTABLET / ORALAB2019-02-2184e616aacf4f…
2026-09-14 22:38:342026-08A207105-006ARIPIPRAZOLE30MGTABLET / ORALAB2019-02-2184e616aacf4f…
2026-08-18 06:07:402026-07A207105-001ARIPIPRAZOLE2MGTABLET / ORALAB2019-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-002ARIPIPRAZOLE5MGTABLET / ORALAB2019-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-003ARIPIPRAZOLE10MGTABLET / ORALAB2019-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-004ARIPIPRAZOLE15MGTABLET / ORALAB2019-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-005ARIPIPRAZOLE20MGTABLET / ORALAB2019-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-006ARIPIPRAZOLE30MGTABLET / ORALAB2019-02-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207105-001ARIPIPRAZOLE2MGTABLET / ORALAB2019-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-002ARIPIPRAZOLE5MGTABLET / ORALAB2019-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-003ARIPIPRAZOLE10MGTABLET / ORALAB2019-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-004ARIPIPRAZOLE15MGTABLET / ORALAB2019-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-005ARIPIPRAZOLE20MGTABLET / ORALAB2019-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-006ARIPIPRAZOLE30MGTABLET / ORALAB2019-02-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-001ARIPIPRAZOLE2MGTABLET / ORALAB2019-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-002ARIPIPRAZOLE5MGTABLET / ORALAB2019-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-003ARIPIPRAZOLE10MGTABLET / ORALAB2019-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-004ARIPIPRAZOLE15MGTABLET / ORALAB2019-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-005ARIPIPRAZOLE20MGTABLET / ORALAB2019-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-006ARIPIPRAZOLE30MGTABLET / ORALAB2019-02-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207105-001ARIPIPRAZOLE2MGTABLET / ORALAB2019-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-002ARIPIPRAZOLE5MGTABLET / ORALAB2019-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-003ARIPIPRAZOLE10MGTABLET / ORALAB2019-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-004ARIPIPRAZOLE15MGTABLET / ORALAB2019-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-005ARIPIPRAZOLE20MGTABLET / ORALAB2019-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-006ARIPIPRAZOLE30MGTABLET / ORALAB2019-02-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-001ARIPIPRAZOLE2MGTABLET / ORALAB2019-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-002ARIPIPRAZOLE5MGTABLET / ORALAB2019-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-003ARIPIPRAZOLE10MGTABLET / ORALAB2019-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-004ARIPIPRAZOLE15MGTABLET / ORALAB2019-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-005ARIPIPRAZOLE20MGTABLET / ORALAB2019-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-006ARIPIPRAZOLE30MGTABLET / ORALAB2019-02-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207105-001ARIPIPRAZOLE2MGTABLET / ORALAB2019-02-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207105-002ARIPIPRAZOLE5MGTABLET / ORALAB2019-02-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207105-003ARIPIPRAZOLE10MGTABLET / ORALAB2019-02-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207105-004ARIPIPRAZOLE15MGTABLET / ORALAB2019-02-21b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A207105-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A207105-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A207105-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A207105-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A207105-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A207105-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A207105-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207105-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207105-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207105-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207105-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207105-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207105-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207105-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207105-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207105-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207105-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207105-004AB1b8a1b40f171c…

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEPreferred Pharmaceuticals, Inc.4894031e-639e-49d8-927a-76d684bf66552025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
ndc (product): 68788-7733
AripiprazoleARIPIPRAZOLEPrefferred Pharmaceuticals Inc.fbb3ac69-8dba-42df-8d6d-ef3d79241edb2025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
ndc (product): 68788-7808
AripiprazoleARIPIPRAZOLENuCare Pharmaceuticals, Inc.27874fe2-3fd6-002d-e063-6294a90a4cd72024-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEA-S Medication Solutionsbf3cf835-4c4e-47cb-be9c-bcb7c2e11cbe2024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
ndc (product): 50090-4863
AripiprazoleARIPIPRAZOLEBryant Ranch Prepackee33be35-abc8-453f-98e9-7974026b7eb02024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
AripiprazoleARIPIPRAZOLEA-S Medication Solutions3ab6af7c-3169-46bf-bd3f-697c81bbcede2024-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207105
application number: ANDA207105
ndc (product): 50090-4665

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 83 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4665AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50090-4665AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50090-4665AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50090-4863AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50090-4863AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50090-4936AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
50090-4936AripiprazoleAripiprazoleA-S Medication SolutionsANDACurrent
67877-430AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-430AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-430AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-430AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-430AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-431AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-431AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-431AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-431AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-431AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-432AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-432AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-432AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-432AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-432AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-433AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-433AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-433AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-433AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-433AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-434AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-434AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-434AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-434AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-434AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-435AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-435AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-435AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-435AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
67877-435AripiprazoleAripiprazoleAscend Laboratories, LLCANDACurrent
68071-2394AripiprazoleAripiprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2676AripiprazoleAripiprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2705AripiprazoleAripiprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2705AripiprazoleAripiprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2708AripiprazoleAripiprazoleNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7733AripiprazoleAripiprazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7733AripiprazoleAripiprazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7733AripiprazoleAripiprazolePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7808AripiprazoleAripiprazolePrefferred Pharmaceuticals Inc.ANDACurrent
68788-7808AripiprazoleAripiprazolePrefferred Pharmaceuticals Inc.ANDACurrent
68788-7808AripiprazoleAripiprazolePrefferred Pharmaceuticals Inc.ANDACurrent
68788-8089AripiprazoleAripiprazolePreferred Pharmaceuticals Inc.ANDACurrent
68788-8089AripiprazoleAripiprazolePreferred Pharmaceuticals Inc.ANDACurrent
70518-2806AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2806AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2806AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2806AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2806AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2820AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2820AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2820AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2820AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2820AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2820AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2869AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2869AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2869AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2869AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2897AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2897AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2897AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2974AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2974AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2974AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-3090AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-3090AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
71335-1687AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1687AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1832AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1832AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1903AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1903AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-1935AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent