Application 088366

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMMONIUM CHLORIDE IN PLASTIC CONTAINER	AMMONIUM CHLORIDE	INJECTABLE;INJECTION	5MEQ/ML	No	Yes

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
A088366-001	AMMONIUM CHLORIDE IN PLASTIC CONTAINER	AMMONIUM CHLORIDE	5MEQ/ML	INJECTABLE / INJECTION		RS	1984-06-13

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	RLD / RS	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A088366-001	AMMONIUM CHLORIDE IN PLASTIC CONTAINER	5MEQ/ML	INJECTABLE / INJECTION	RS	1984-06-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088366-001	AMMONIUM CHLORIDE IN PLASTIC CONTAINER	5MEQ/ML	INJECTABLE / INJECTION	RS	1984-06-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A088366-001	AMMONIUM CHLORIDE IN PLASTIC CONTAINER	5MEQ/ML	INJECTABLE / INJECTION	RS	1984-06-13	`a50c72e98297…`

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	Join
Ammonium muriaticum	AMMONIUM CHLORIDE	Boiron	687eae27-d686-1a0f-e053-2a91aa0a124a	2023-10-16	Name fallback generic name: AMMONIUM CHLORIDE
Ammonium muriaticum	AMMONIUM CHLORIDE	Boiron	84b58da5-40e4-f3c1-e053-2991aa0aeb82	2023-08-29	Name fallback generic name: AMMONIUM CHLORIDE
Ammonium muriaticum	AMMONIUM CHLORIDE	Boiron	8427af63-5644-be0c-e053-2a91aa0a255d	2023-05-16	Name fallback generic name: AMMONIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

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