Viewing data from:

BALANCED SALT

ANDA

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE | A091387 | B BRAUN MEDICAL INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: BSS(TE code: AT)

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Alcon Research, Ltd. FDA-2007-P-0129 · 7 docket documents Alcon Research, Ltd. filed this citizen petition on April 18, 2007, requesting expedited enforcement action by the FDA Commissioner to remove illegally marketed unapproved ophthalmic Balanced Salt Solution drugs from the market and improperly classified medical devices or over-the-counter irrigating	Other	2008-07-14	Withdrawn	Alcon Research, Ltd.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 17, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML

0 patents0 exclusivities▴

SOLUTION;IRRIGATION | Approved: Feb 3, 2010

No patent or exclusivity listings for this strength.