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Details for New Drug Application (NDA): 204071

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NDA 204071 describes SODIUM POLYSTYRENE SULFONATE, which is a drug marketed by Citrusphrma, Carolina Medcl, Cedar Pharms, Invatech Pharma, Morton Grove, Belcher Pharms Llc, Epic Pharma Llc, Roxane, Nuvo Pharm Inc, Wockhardt, and Paddock Llc, and is included in twelve NDAs. It is available from eight suppliers. Additional details are available on the SODIUM POLYSTYRENE SULFONATE profile page.

The generic ingredient in SODIUM POLYSTYRENE SULFONATE is sodium polystyrene sulfonate. There are one thousand three hundred and thirty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the sodium polystyrene sulfonate profile page.

Summary for NDA: 204071

Suppliers and Packaging for NDA: 204071

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sodium polystyrene sulfonate
POWDER;ORAL, RECTAL 204071 ANDA Marlex Pharmaceuticals Inc 10135-146 10135-146-14 15 g in 1 BOTTLE, PLASTIC (10135-146-14)
sodium polystyrene sulfonate
POWDER;ORAL, RECTAL 204071 ANDA Marlex Pharmaceuticals Inc 10135-146 10135-146-17 454 g in 1 JAR (10135-146-17)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORAL, RECTALStrength454GM/BOT
Approval Date:Nov 28, 2014TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORAL, RECTALStrength15GM/BOT
Approval Date:Nov 28, 2014TE:RLD:No

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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 verifification 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.