Application 070278

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HALOPERIDOLHALOPERIDOLTABLET;ORAL2MGNoYes
002HALOPERIDOLHALOPERIDOLTABLET;ORAL10MGNoNo
003HALOPERIDOLHALOPERIDOLTABLET;ORAL20MGNoNo
004HALOPERIDOLHALOPERIDOLTABLET;ORAL1MGNoNo
005HALOPERIDOLHALOPERIDOLTABLET;ORAL5MGNoNo
006HALOPERIDOLHALOPERIDOLTABLET;ORAL0.5MGNoNo

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
A070278-001HALOPERIDOLHALOPERIDOL2MGTABLET / ORALABRS1986-06-10
A070278-002HALOPERIDOLHALOPERIDOL10MGTABLET / ORALAB2009-07-16
A070278-003HALOPERIDOLHALOPERIDOL20MGTABLET / ORAL2009-07-16
A070278-004HALOPERIDOLHALOPERIDOL1MGTABLET / ORALAB1986-06-10
A070278-005HALOPERIDOLHALOPERIDOL5MGTABLET / ORALAB1986-06-10
A070278-006HALOPERIDOLHALOPERIDOL0.5MGTABLET / ORALAB1986-06-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A070278-001AB
A070278-002AB
A070278-004AB
A070278-005AB
A070278-006AB

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 UTC2026-02A070278-001HALOPERIDOL2MGTABLET / ORALABRS1986-06-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070278-002HALOPERIDOL10MGTABLET / ORALAB2009-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070278-003HALOPERIDOL20MGTABLET / ORALAB2009-07-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070278-004HALOPERIDOL1MGTABLET / ORALAB1986-06-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070278-005HALOPERIDOL5MGTABLET / ORALAB1986-06-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070278-006HALOPERIDOL0.5MGTABLET / ORALAB1986-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070278-001HALOPERIDOL2MGTABLET / ORALABRS1986-06-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070278-002HALOPERIDOL10MGTABLET / ORALAB2009-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070278-003HALOPERIDOL20MGTABLET / ORALAB2009-07-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070278-004HALOPERIDOL1MGTABLET / ORALAB1986-06-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070278-005HALOPERIDOL5MGTABLET / ORALAB1986-06-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070278-006HALOPERIDOL0.5MGTABLET / ORALAB1986-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A070278-001HALOPERIDOL2MGTABLET / ORALABRS1986-06-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070278-002HALOPERIDOL10MGTABLET / ORALAB2009-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070278-003HALOPERIDOL20MGTABLET / ORALAB2009-07-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070278-004HALOPERIDOL1MGTABLET / ORALAB1986-06-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070278-005HALOPERIDOL5MGTABLET / ORALAB1986-06-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070278-006HALOPERIDOL0.5MGTABLET / ORALAB1986-06-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070278-001HALOPERIDOL2MGTABLET / ORALABRS1986-06-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070278-002HALOPERIDOL10MGTABLET / ORALAB2009-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070278-003HALOPERIDOL20MGTABLET / ORALAB2009-07-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070278-004HALOPERIDOL1MGTABLET / ORALAB1986-06-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070278-005HALOPERIDOL5MGTABLET / ORALAB1986-06-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070278-006HALOPERIDOL0.5MGTABLET / ORALAB1986-06-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070278-001HALOPERIDOL2MGTABLET / ORALABRS1986-06-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070278-002HALOPERIDOL10MGTABLET / ORALAB2009-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070278-003HALOPERIDOL20MGTABLET / ORALAB2009-07-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070278-004HALOPERIDOL1MGTABLET / ORALAB1986-06-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070278-005HALOPERIDOL5MGTABLET / ORALAB1986-06-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070278-006HALOPERIDOL0.5MGTABLET / ORALAB1986-06-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070278-001HALOPERIDOL2MGTABLET / ORALABRS1986-06-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070278-002HALOPERIDOL10MGTABLET / ORALAB2009-07-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070278-003HALOPERIDOL20MGTABLET / ORALAB2009-07-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070278-004HALOPERIDOL1MGTABLET / ORALAB1986-06-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070278-005HALOPERIDOL5MGTABLET / ORALAB1986-06-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070278-006HALOPERIDOL0.5MGTABLET / ORALAB1986-06-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070278-001HALOPERIDOL2MGTABLET / ORALABRS1986-06-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070278-002HALOPERIDOL10MGTABLET / ORALAB2009-07-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070278-003HALOPERIDOL20MGTABLET / ORALAB2009-07-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070278-004HALOPERIDOL1MGTABLET / ORALAB1986-06-102680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 241 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A070278-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070278-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070278-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070278-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070278-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070278-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070278-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070278-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070278-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070278-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070278-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070278-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070278-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070278-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070278-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070278-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070278-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070278-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070278-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070278-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070278-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070278-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070278-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070278-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070278-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070278-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070278-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070278-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070278-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070278-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070278-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070278-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070278-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070278-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070278-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070278-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070278-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070278-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070278-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070278-004AB12680178bc6a6…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HaloperidolHALOPERIDOLCardinal Health 107, LLC8ca14b79-6671-4e44-aa34-6564a92aa1972025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070278
application number: ANDA070278
ndc (product): 55154-5059
HaloperidolHALOPERIDOLMylan Institutional Inc.ad7d2f17-a4e8-4ebc-9baf-5983ac6267822025-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070278
application number: ANDA070278
ndc (product): 51079-736
ndc (product): 51079-735
ndc (product): 51079-734
ndc (product): 51079-431
ndc (product): 51079-733
HaloperidolHALOPERIDOLCoupler LLC2ccc2e26-de98-af81-e063-6394a90a040b2025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070278
application number: ANDA070278
HaloperidolHALOPERIDOLMylan Pharmaceuticals Inc.c559b0b0-4087-d12a-e718-c18ccb6811e62025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070278
application number: ANDA070278
ndc (product): 0378-0351
ndc (product): 0378-0257
ndc (product): 0378-0335
ndc (product): 0378-0334
ndc (product): 0378-0327
ndc (product): 0378-0214

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 84 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0214HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0214HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0214HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0214HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0214HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0214HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0257HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0257HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0257HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0257HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0257HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0257HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0327HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0327HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0327HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0327HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0327HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0327HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0334HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0334HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0334HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0334HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0334HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0334HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0335HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0335HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0335HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0335HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0335HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0335HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0351HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0351HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0351HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0351HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0351HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0378-0351HaloperidolhaloperidolMylan Pharmaceuticals Inc.ANDACurrent
0615-2594HaloperidolHaloperidolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2595HaloperidolHaloperidolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2596HaloperidolHaloperidolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2597HaloperidolHaloperidolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43063-551HaloperidolhaloperidolPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-3468HaloperidolhaloperidolA-S Medication SolutionsANDACurrent
50090-4400HaloperidolhaloperidolA-S Medication SolutionsANDACurrent
50090-4400HaloperidolhaloperidolA-S Medication SolutionsANDACurrent
51079-431HaloperidolhaloperidolMylan Institutional Inc.ANDACurrent
51079-431HaloperidolhaloperidolMylan Institutional Inc.ANDACurrent
51079-431HaloperidolhaloperidolMylan Institutional Inc.ANDACurrent
51079-733HaloperidolhaloperidolMylan Institutional Inc.ANDACurrent
51079-733HaloperidolhaloperidolMylan Institutional Inc.ANDACurrent
51079-733HaloperidolhaloperidolMylan Institutional Inc.ANDACurrent
51079-734HaloperidolhaloperidolMylan Institutional Inc.ANDACurrent
51079-734HaloperidolhaloperidolMylan Institutional Inc.ANDACurrent
51079-734HaloperidolhaloperidolMylan Institutional Inc.ANDACurrent
51079-735HaloperidolhaloperidolMylan Institutional Inc.ANDACurrent
51079-735HaloperidolhaloperidolMylan Institutional Inc.ANDACurrent
51079-735HaloperidolhaloperidolMylan Institutional Inc.ANDACurrent
51079-736HaloperidolhaloperidolMylan Institutional Inc.ANDACurrent
51079-736HaloperidolhaloperidolMylan Institutional Inc.ANDACurrent
51079-736HaloperidolhaloperidolMylan Institutional Inc.ANDACurrent
53808-0264HaloperidolhaloperidolState of Florida DOH Central PharmacyANDACurrent
53808-0372HaloperidolhaloperidolState of Florida DOH Central PharmacyANDACurrent
53808-0631HaloperidolhaloperidolState of Florida DOH Central PharmacyANDACurrent
53808-0840HaloperidolhaloperidolState of Florida DOH Central PharmacyANDACurrent
55154-5059HaloperidolhaloperidolCardinal HealthANDACurrent
55154-5059HaloperidolhaloperidolCardinal HealthANDACurrent
55154-5059HaloperidolhaloperidolCardinal HealthANDACurrent
55154-5059HaloperidolhaloperidolCardinal Health 107, LLCANDACurrent
64725-0214HaloperidolhaloperidolTYA PharmaceuticalsANDACurrent
64725-0327HaloperidolhaloperidolTYA PharmaceuticalsANDACurrent
67046-268HaloperidolhaloperidolContract Pharmacy Services-PAANDACurrent
70518-0023HaloperidolhaloperidolREMEDYREPACK INC.ANDACurrent
70518-0023HaloperidolhaloperidolREMEDYREPACK INC.ANDACurrent
70518-0728HaloperidolhaloperidolREMEDYREPACK INC.ANDACurrent
70518-0728HaloperidolhaloperidolREMEDYREPACK INC.ANDACurrent
70518-0728HaloperidolhaloperidolREMEDYREPACK INC.ANDACurrent
70518-1720HaloperidolhaloperidolREMEDYREPACK INC.ANDACurrent
70518-1720HaloperidolhaloperidolREMEDYREPACK INC.ANDACurrent
70518-2204HaloperidolhaloperidolREMEDYREPACK INC.ANDACurrent
70518-2204HaloperidolhaloperidolREMEDYREPACK INC.ANDACurrent
70518-2204HaloperidolhaloperidolREMEDYREPACK INC.ANDACurrent