FDA.reportPublic FDA data

Application 071173

Type
ANDA
Sponsor
INNOGENIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HALOPERIDOLHALOPERIDOLTABLET;ORAL10MGNoNo
002HALOPERIDOLHALOPERIDOLTABLET;ORAL0.5MGNoNo
003HALOPERIDOLHALOPERIDOLTABLET;ORAL1MGNoNo
004HALOPERIDOLHALOPERIDOLTABLET;ORAL2MGNoNo
005HALOPERIDOLHALOPERIDOLTABLET;ORAL5MGNoNo
006HALOPERIDOLHALOPERIDOLTABLET;ORAL20MGNoNo

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
A071173-001HALOPERIDOLHALOPERIDOL10MGTABLET / ORALAB1988-01-07
A071173-002HALOPERIDOLHALOPERIDOL0.5MGTABLET / ORALAB1987-01-02
A071173-003HALOPERIDOLHALOPERIDOL1MGTABLET / ORALAB1987-01-02
A071173-004HALOPERIDOLHALOPERIDOL2MGTABLET / ORALAB1987-01-02
A071173-005HALOPERIDOLHALOPERIDOL5MGTABLET / ORALAB1988-01-07
A071173-006HALOPERIDOLHALOPERIDOL20MGTABLET / ORALAB1988-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071173-001AB
A071173-002AB
A071173-003AB
A071173-004AB
A071173-005AB
A071173-006AB

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 22:38:342026-08A071173-001HALOPERIDOL10MGTABLET / ORALAB1988-01-0784e616aacf4f…
2026-09-14 22:38:342026-08A071173-002HALOPERIDOL0.5MGTABLET / ORALAB1987-01-0284e616aacf4f…
2026-09-14 22:38:342026-08A071173-003HALOPERIDOL1MGTABLET / ORALAB1987-01-0284e616aacf4f…
2026-09-14 22:38:342026-08A071173-004HALOPERIDOL2MGTABLET / ORALAB1987-01-0284e616aacf4f…
2026-09-14 22:38:342026-08A071173-005HALOPERIDOL5MGTABLET / ORALAB1988-01-0784e616aacf4f…
2026-09-14 22:38:342026-08A071173-006HALOPERIDOL20MGTABLET / ORALAB1988-01-0784e616aacf4f…
2026-08-18 06:07:402026-07A071173-001HALOPERIDOL10MGTABLET / ORALAB1988-01-07caaa826d4ba7…
2026-08-18 06:07:402026-07A071173-002HALOPERIDOL0.5MGTABLET / ORALAB1987-01-02caaa826d4ba7…
2026-08-18 06:07:402026-07A071173-003HALOPERIDOL1MGTABLET / ORALAB1987-01-02caaa826d4ba7…
2026-08-18 06:07:402026-07A071173-004HALOPERIDOL2MGTABLET / ORALAB1987-01-02caaa826d4ba7…
2026-08-18 06:07:402026-07A071173-005HALOPERIDOL5MGTABLET / ORALAB1988-01-07caaa826d4ba7…
2026-08-18 06:07:402026-07A071173-006HALOPERIDOL20MGTABLET / ORALAB1988-01-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071173-001HALOPERIDOL10MGTABLET / ORALAB1988-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-002HALOPERIDOL0.5MGTABLET / ORALAB1987-01-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-003HALOPERIDOL1MGTABLET / ORALAB1987-01-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-004HALOPERIDOL2MGTABLET / ORALAB1987-01-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-005HALOPERIDOL5MGTABLET / ORALAB1988-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-006HALOPERIDOL20MGTABLET / ORALAB1988-01-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-001HALOPERIDOL10MGTABLET / ORALAB1988-01-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-002HALOPERIDOL0.5MGTABLET / ORALAB1987-01-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-003HALOPERIDOL1MGTABLET / ORALAB1987-01-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-004HALOPERIDOL2MGTABLET / ORALAB1987-01-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-005HALOPERIDOL5MGTABLET / ORALAB1988-01-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-006HALOPERIDOL20MGTABLET / ORALAB1988-01-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A071173-001HALOPERIDOL10MGTABLET / ORALAB1988-01-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-002HALOPERIDOL0.5MGTABLET / ORALAB1987-01-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-003HALOPERIDOL1MGTABLET / ORALAB1987-01-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-004HALOPERIDOL2MGTABLET / ORALAB1987-01-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-005HALOPERIDOL5MGTABLET / ORALAB1988-01-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-006HALOPERIDOL20MGTABLET / ORALAB1988-01-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-001HALOPERIDOL10MGTABLET / ORALAB1988-01-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-002HALOPERIDOL0.5MGTABLET / ORALAB1987-01-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-003HALOPERIDOL1MGTABLET / ORALAB1987-01-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-004HALOPERIDOL2MGTABLET / ORALAB1987-01-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-005HALOPERIDOL5MGTABLET / ORALAB1988-01-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-006HALOPERIDOL20MGTABLET / ORALAB1988-01-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-001HALOPERIDOL10MGTABLET / ORALAB1988-01-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-002HALOPERIDOL0.5MGTABLET / ORALAB1987-01-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-003HALOPERIDOL1MGTABLET / ORALAB1987-01-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-004HALOPERIDOL2MGTABLET / ORALAB1987-01-02b8a1b40f171c…

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
2026-09-14 22:38:342026-08A071173-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A071173-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A071173-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A071173-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A071173-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A071173-006AB184e616aacf4f…
2026-08-18 06:07:402026-07A071173-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071173-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071173-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071173-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071173-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071173-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071173-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071173-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071173-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071173-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071173-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071173-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071173-004AB1b8a1b40f171c…

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 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HaloperidolHALOPERIDOLBryant Ranch Prepackf1c56d0d-87d3-40ef-9578-0d99fbae12fe2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
ndc (product): 63629-9272
HaloperidolHALOPERIDOLBryant Ranch Prepack88031df0-90bd-4444-9503-1b4612e3856b2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
ndc (product): 63629-9270
HaloperidolHALOPERIDOLBryant Ranch Prepackb9e8f5f2-6d59-4a2c-8ccf-88bb58753f602024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLBryant Ranch Prepacka8e9d675-135c-4b5d-91d0-1ef0d295535c2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
ndc (product): 63629-9273
HaloperidolHALOPERIDOLBryant Ranch Prepackf20769bc-98a3-419a-ba36-2e9737050cd92024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
ndc (product): 63629-9274
HaloperidolHALOPERIDOLBryant Ranch Prepack33dca652-c60c-44e0-9303-ea55a431fdcd2024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
ndc (product): 63629-9271
HaloperidolHALOPERIDOLBryant Ranch Prepackc3b35c6c-e339-439a-b75f-dd645e08a9592024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLBryant Ranch Prepack1171bd60-7105-4b70-a24c-f2bc8c52a8c02024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLBryant Ranch Prepacka79c12f2-cf98-4337-8b6a-7b9ef2afa9d52024-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
HaloperidolHALOPERIDOLAmici Pharmaceuticals, LLC9a9e20dd-646a-4fe9-a345-1b5bda8e77752022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071173
application number: ANDA071173
ndc (product): 69292-582
ndc (product): 69292-586
ndc (product): 69292-590
ndc (product): 69292-584
ndc (product): 69292-588
ndc (product): 69292-580

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 · 68 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7240HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
0904-7241HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
0904-7242HaloperidolHaloperidolMajor PharmaceuticalsANDACurrent
10135-752HaloperidolHaloperidolMarlex Pharmaceuticals, Inc.ANDACurrent
10135-753HaloperidolHaloperidolMarlex Pharmaceuticals, Inc.ANDACurrent
10135-754HaloperidolHaloperidolMarlex Pharmaceuticals, Inc.ANDACurrent
10135-755HaloperidolHaloperidolMarlex Pharmaceuticals, Inc.ANDACurrent
10135-756HaloperidolHaloperidolMarlex Pharmaceuticals, Inc.ANDACurrent
10135-757HaloperidolHaloperidolMarlex Pharmaceuticals, Inc.ANDACurrent
17856-0730HaloperidolHaloperidolATLANTIC BIOLOGICALS CORP.ANDACurrent
50090-5989HaloperidolHaloperidolA-S Medication SolutionsANDACurrent
58657-700HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-700HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-701HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-701HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-702HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-702HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-703HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-703HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-704HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-704HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-705HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
58657-705HaloperidolHaloperidolMethod Pharmaceuticals, LLCANDACurrent
63629-2326HaloperidolHaloperidolBryant Ranch PrepackANDACurrent
63629-2326HaloperidolHaloperidolBryant Ranch PrepackANDACurrent
63629-9270HaloperidolHaloperidolBryant Ranch PrepackANDACurrent
63629-9271HaloperidolHaloperidolBryant Ranch PrepackANDACurrent
63629-9272HaloperidolHaloperidolBryant Ranch PrepackANDACurrent
63629-9273HaloperidolHaloperidolBryant Ranch PrepackANDACurrent
63629-9274HaloperidolHaloperidolBryant Ranch PrepackANDACurrent
63629-9275HaloperidolHaloperidolBryant Ranch PrepackANDACurrent
69292-580HaloperidolHaloperidolAmici Pharmaceuticals, LLCANDACurrent
69292-582HaloperidolHaloperidolAmici Pharmaceuticals, LLCANDACurrent
69292-584HaloperidolHaloperidolAmici Pharmaceuticals, LLCANDACurrent
69292-586HaloperidolHaloperidolAmici Pharmaceuticals, LLCANDACurrent
69292-588HaloperidolHaloperidolAmici Pharmaceuticals, LLCANDACurrent
69292-590HaloperidolHaloperidolAmici Pharmaceuticals, LLCANDACurrent
70518-2680HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2680HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2680HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2680HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2682HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2682HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2682HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2682HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2687HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2687HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2687HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2687HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-3021HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-3437HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-3437HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-3440HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-3500HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-3587HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-3608HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
71247-150HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-150HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-151HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-151HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-152HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-152HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-153HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-153HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-154HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-154HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-155HaloperidolHaloperidolInnogenix, Inc.ANDACurrent
71247-155HaloperidolHaloperidolInnogenix, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53954ORIG2018-05-01