Application 075503

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BALANCED SALT	CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE	SOLUTION;IRRIGATION	0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML	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
A075503-001	BALANCED SALT	CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE	0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML	SOLUTION / IRRIGATION			2006-09-27

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	Product TE source text	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A075503-001	BALANCED SALT	0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML	SOLUTION / IRRIGATION		2006-09-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075503-001	BALANCED SALT	0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML	SOLUTION / IRRIGATION	AT	2006-09-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075503-001	BALANCED SALT	0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML	SOLUTION / IRRIGATION		2006-09-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075503-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075503-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075503-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075503-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075503-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075503-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075503-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075503-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075503-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075503-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075503-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075503-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075503-001	AT	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075503-001	AT	1	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Balanced Salt	SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE	B. Braun Medical Inc.	74ab8883-0a5f-46b4-8998-9358f6fd4ef4	2024-03-13	Warnings, Adverse reactions	Name fallback brand name: Balanced Salt

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17478-920	BALANCED SALT	Calcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, Sodium Chloride, Sodium Citrate	Akorn	ANDA	Current
17478-920	BALANCED SALT	Calcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, Sodium Chloride, Sodium Citrate	Akorn, Inc.	ANDA	Current
17478-920	BALANCED SALT	Calcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, Sodium Chloride, Sodium Citrate	Akorn, Inc.	ANDA	Current
17478-921	Balanced Salt	Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate and Trisodium Citrate Dihydrate	Akorn, Inc.	ANDA	Current
17478-921	Balanced Salt	Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate and Trisodium Citrate Dihydrate	Akorn	ANDA	Current
17478-921	Balanced Salt	Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate and Trisodium Citrate Dihydrate	Akorn, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8697	ORIG	2006-10-02