Application 201833

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	INJECTABLE;INJECTION	9MG/ML	No	No
002	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	SOLUTION;INJECTION	90MG/10ML (9MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201833-001	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	18MG/2ML (9MG/ML)	SOLUTION / INJECTION			2013-09-24
A201833-002	SODIUM CHLORIDE 0.9%	SODIUM CHLORIDE	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP		2015-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201833-002	AP

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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A201833-001	SODIUM CHLORIDE 0.9%	18MG/2ML (9MG/ML)	SOLUTION / INJECTION			2013-09-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A201833-002	SODIUM CHLORIDE 0.9%	90MG/10ML (9MG/ML)	SOLUTION / INJECTION	AP		2015-01-07	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A201833-002	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Chloride	SODIUM CHLORIDE	Hikma Pharmaceuticals USA Inc.	e5ee8caa-b6ca-45ba-98fb-8305e6282141	2024-04-10	Adverse reactions	Exact identifier application applno (ANDA): 201833 application number: ANDA201833 ndc (product): 0641-6144 ndc (product): 0641-0497

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-0497	Sodium Chloride	Sodium Chloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-0497	Sodium Chloride	Sodium Chloride	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6144	Sodium Chloride	Sodium Chloride	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6144	Sodium Chloride	Sodium Chloride	West-Ward Pharmaceuticals Corp.	ANDA	Current