Application 070278

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	2MG	No	Yes
002	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	10MG	No	No
003	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	20MG	No	No
004	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	1MG	No	No
005	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	5MG	No	No
006	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	0.5MG	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A070278-001	HALOPERIDOL	HALOPERIDOL	2MG	TABLET / ORAL	AB	1986-06-10
A070278-002	HALOPERIDOL	HALOPERIDOL	10MG	TABLET / ORAL		2009-07-16
A070278-003	HALOPERIDOL	HALOPERIDOL	20MG	TABLET / ORAL		2009-07-16
A070278-004	HALOPERIDOL	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-06-10
A070278-005	HALOPERIDOL	HALOPERIDOL	5MG	TABLET / ORAL	AB	1986-06-10
A070278-006	HALOPERIDOL	HALOPERIDOL	0.5MG	TABLET / ORAL	AB	1986-06-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB		1986-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL			2009-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL			2009-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB		1986-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL			2009-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-005	HALOPERIDOL	5MG	TABLET / ORAL	AB		1986-06-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-006	HALOPERIDOL	0.5MG	TABLET / ORAL	AB		1986-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-001	HALOPERIDOL	2MG	TABLET / ORAL	AB	RS	1986-06-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-002	HALOPERIDOL	10MG	TABLET / ORAL	AB		2009-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-003	HALOPERIDOL	20MG	TABLET / ORAL	AB		2009-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-004	HALOPERIDOL	1MG	TABLET / ORAL	AB		1986-06-10	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 250 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A070278-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070278-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070278-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070278-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070278-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070278-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070278-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070278-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070278-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070278-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070278-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070278-001	AB	1	`03ed91905a0d…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol	HALOPERIDOL	Cardinal Health 107, LLC	8ca14b79-6671-4e44-aa34-6564a92aa197	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070278 application number: ANDA070278
Haloperidol	HALOPERIDOL	Mylan Institutional Inc.	ad7d2f17-a4e8-4ebc-9baf-5983ac626782	2025-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070278 application number: ANDA070278
Haloperidol	HALOPERIDOL	Coupler LLC	2ccc2e26-de98-af81-e063-6394a90a040b	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070278 application number: ANDA070278
Haloperidol	HALOPERIDOL	Mylan Pharmaceuticals Inc.	c559b0b0-4087-d12a-e718-c18ccb6811e6	2025-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070278 application number: ANDA070278

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 2 of 2 · 84 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-2248	Haloperidol	haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-2248	Haloperidol	haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-2248	Haloperidol	haloperidol	REMEDYREPACK INC.	ANDA	Current
70518-2361	Haloperidol	haloperidol	REMEDYREPACK INC.	ANDA	Current