Application 040574

Type: ANDA
Sponsor: PRINSTON INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	TABLET;ORAL	25MG	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
2019-12-13 00:20 UTC	2019-12	A040574-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	A040574-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040574-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040574-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040574-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040574-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040574-001	HYDROXYZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2005-05-27	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040574-001	AB	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	A040574-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040574-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040574-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040574-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040574-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040574-001	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 8 of 8 · 141 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydroxyzine hydrochloride	HYDROXYZINE HYDROCHLORIDE	Proficient Rx LP	2da6dd2f-90e2-464a-ad2a-292575cb0428	2022-05-02	Warnings, Adverse reactions	Name fallback brand name: Hydroxyzine hydrochloride generic name: HYDROXYZINE HYDROCHLORIDE

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63187-244	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	Proficient Rx LP	ANDA	Current
66336-086	Hydroxyzine Hydrochloride	hydroxyzine hydrochloride	Dispensing Solutions, Inc.	ANDA	Current