Application 087447

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLOROPROCAINE HYDROCHLORIDE	CHLOROPROCAINE HYDROCHLORIDE	INJECTABLE;INJECTION	2%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A087447-001	CHLOROPROCAINE HYDROCHLORIDE	CHLOROPROCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION			1982-04-16

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A087447-001	CHLOROPROCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	1982-04-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087447-001	CHLOROPROCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	1982-04-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A087447-001	CHLOROPROCAINE HYDROCHLORIDE	2%	INJECTABLE / INJECTION	1982-04-16	`a50c72e98297…`

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	A087447-001	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087447-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087447-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087447-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087447-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087447-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087447-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087447-001	AP	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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chloroprocaine Hydrochloride	CHLOROPROCAINE HYDROCHLORIDE	ProPharma Distribution	4305ab6b-6038-9daa-e063-6294a90a018e	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Chloroprocaine Hydrochloride generic name: CHLOROPROCAINE HYDROCHLORIDE
Nesacaine	CHLOROPROCAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	a844e68a-1462-40e4-be5e-f56214906eb9	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: CHLOROPROCAINE HYDROCHLORIDE
Chloroprocaine Hydrochloride	CHLOROPROCAINE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	e21e24d5-0535-4962-b9ed-7957fe4ed3db	2022-02-25	Warnings, Adverse reactions	Name fallback brand name: Chloroprocaine Hydrochloride generic name: CHLOROPROCAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.