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SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

ANDA

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE | A202511 | NOVEL LABORATORIES INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: SUPREP BOWEL PREP KIT(TE code: AA)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
BRAINTREE LABORATORIES, INC. v. LUPIN ATLANTIS HOLDINGS SA 3:2011cv01341 1 patentANDA 202511sodium sulfate, potassium sulfate and magnesium sulfate oral lavage solution	D.N.J.	2011-03-09	Terminated 2015-06-04	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 3, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Feb 23, 2017

No patent or exclusivity listings for this strength.