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Last Updated: September 21, 2021

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Details for New Drug Application (NDA): 213135


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NDA 213135 describes SUTAB (COPACKAGED), which is a drug marketed by Braintree Labs and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the SUTAB (COPACKAGED) profile page.

The generic ingredient in SUTAB (COPACKAGED) is magnesium sulfate; potassium chloride; sodium sulfate. There are one hundred and forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the magnesium sulfate; potassium chloride; sodium sulfate profile page.
Summary for 213135
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 213135
Generic Entry Date for 213135*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 213135
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUTAB (COPACKAGED) magnesium sulfate; potassium chloride; sodium sulfate TABLET;ORAL 213135 NDA Braintree Laboratories, Inc. 52268-201 52268-201-01 2 BOTTLE, PLASTIC in 1 KIT (52268-201-01) > 12 TABLET in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.225GM;0.188GM;1.479GM
Approval Date:Nov 10, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 10, 2023
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Try it FreePatent Expiration:Aug 4, 2037Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try it FreePatent Expiration:Aug 4, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:GASTROINTESTINAL TABLETS INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.