Application 071207

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALOPERIDOL	HALOPERIDOL	TABLET;ORAL	1MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071207-001	HALOPERIDOL	1MG	TABLET / ORAL	AB	1986-11-17	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	A071207-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071207-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071207-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071207-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071207-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071207-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071207-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071207-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071207-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071207-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071207-001	AB	1	`ea99ee380514…`

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 5 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol	HALOPERIDOL LACTATE	Fresenius Kabi USA, LLC	b1ad2abd-a9d6-44e3-957b-36a73260f4f5	2022-01-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
HALOPERIDOL	HALOPERIDOL LACTATE	HF Acquisition Co LLC, DBA HealthFirst	beb6d1cf-98db-d0a5-e053-2995a90ace90	2021-03-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1392	Haloperidol	Haloperidol	Sandoz Inc	ANDA	Current
0781-1392	Haloperidol	Haloperidol	Sandoz Inc	ANDA	Current
0904-5923	Haloperidol	Haloperidol	Major Pharmaceuticals	ANDA	Current
53808-0654	Haloperidol	Haloperidol	State of Florida DOH Central Pharmacy	ANDA	Current
68258-7077	Haloperidol	Haloperidol	Dispensing Solutions, Inc.	ANDA	Current