FDA.reportPublic FDA data

Application 204838

Type
ANDA
Sponsor
AMNEAL PHARMS

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
A204838-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2016-06-17
A204838-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2016-06-17
A204838-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2016-06-17
A204838-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2016-06-17
A204838-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2016-06-17
A204838-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORALAB2016-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204838-001AB
A204838-002AB
A204838-003AB
A204838-004AB
A204838-005AB
A204838-006AB

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 22:38:342026-08A204838-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-06-1784e616aacf4f…
2026-09-14 22:38:342026-08A204838-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-06-1784e616aacf4f…
2026-09-14 22:38:342026-08A204838-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-06-1784e616aacf4f…
2026-09-14 22:38:342026-08A204838-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-06-1784e616aacf4f…
2026-09-14 22:38:342026-08A204838-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-06-1784e616aacf4f…
2026-09-14 22:38:342026-08A204838-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-06-1784e616aacf4f…
2026-08-18 06:07:402026-07A204838-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-06-17caaa826d4ba7…
2026-08-18 06:07:402026-07A204838-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-06-17caaa826d4ba7…
2026-08-18 06:07:402026-07A204838-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-06-17caaa826d4ba7…
2026-08-18 06:07:402026-07A204838-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-06-17caaa826d4ba7…
2026-08-18 06:07:402026-07A204838-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-06-17caaa826d4ba7…
2026-08-18 06:07:402026-07A204838-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-06-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204838-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204838-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204838-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204838-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204838-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-06-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204838-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-06-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204838-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204838-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204838-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204838-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204838-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204838-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-06-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204838-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-06-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204838-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-06-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204838-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204838-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204838-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-06-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204838-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-06-17b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204838-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204838-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204838-005AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204838-006AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204838-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204838-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204838-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204838-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204838-005AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204838-006AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204838-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204838-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204838-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204838-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204838-005AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204838-006AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204838-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204838-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204838-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204838-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204838-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204838-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204838-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204838-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204838-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204838-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204838-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204838-006AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204838-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204838-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204838-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204838-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204838-005AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204838-006AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204838-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204838-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204838-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204838-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204838-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204838-006AB174a2ff9319b5…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLEREMEDYREPACK INC.a1191a90-eb83-4a59-948c-b9774d2c83a52026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204838
application number: ANDA204838
ndc (product): 70518-0970
AripiprazoleARIPIPRAZOLEAmneal Pharmaceuticals LLC06dda03f-8481-46d6-af02-4f51e1a3a0652025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204838
application number: ANDA204838
ndc (product): 65162-901
ndc (product): 65162-898
ndc (product): 65162-902
ndc (product): 65162-896
ndc (product): 65162-899
ndc (product): 65162-897
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack96172aa4-9e13-4eca-83d5-85a88c1782d32024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204838
application number: ANDA204838
ndc (product): 63629-7774
AripiprazoleARIPIPRAZOLEProficient Rx LPdbdc8fbe-c75f-4f17-a2cd-9f23802dcc5d2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204838
application number: ANDA204838
ndc (product): 63187-965

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 1 · 74 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50436-0897AripiprazoleAripiprazoleUnit Dose ServicesANDACurrent
53808-1101AripiprazoleAripiprazoleDOH CENTRAL PHARMACYANDACurrent
63187-965AripiprazoleAripiprazoleProficient Rx LPANDACurrent
63187-965AripiprazoleAripiprazoleProficient Rx LPANDACurrent
63629-7774AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
63629-7774AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
63629-7774AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
65162-896AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-896AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-896AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-896AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-896AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-897AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-897AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-897AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-897AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-897AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-898AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-898AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-898AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-898AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-898AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-899AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-899AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-899AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-899AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-899AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-901AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-901AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-901AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-901AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-901AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-902AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-902AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-902AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-902AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
65162-902AripiprazoleAripiprazoleAmneal Pharmaceuticals LLCANDACurrent
70518-0896AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0896AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0896AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0896AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0970AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0970AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0970AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0970AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0970AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0970AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0976AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0976AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0976AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-0976AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1421AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1421AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1421AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1421AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1421AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1421AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1421AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1421AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1624AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-1624AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2475AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2475AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2514AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2514AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2565AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2565AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2565AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2567AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2567AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-2567AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
70518-3380AripiprazoleAripiprazoleREMEDYREPACK INC.ANDACurrent
71335-0609AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent
71335-0667AripiprazoleAripiprazoleBryant Ranch PrepackANDACurrent