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Details for New Drug Application (NDA): 203802

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NDA 203802 describes PALIPERIDONE, which is a drug marketed by Mylan Pharms Inc and Actavis Labs Fl Inc and is included in two NDAs. It is available from four suppliers. Additional details are available on the PALIPERIDONE profile page.

The generic ingredient in PALIPERIDONE is paliperidone. There are thirty-three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the paliperidone profile page.

Summary for NDA: 203802

Tradename:
PALIPERIDONE
Applicant:
Mylan Pharms Inc
Ingredient:
paliperidone
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

Pharmacology for NDA: 203802

Suppliers and Packaging for NDA: 203802

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PALIPERIDONE
paliperidone
TABLET, EXTENDED RELEASE;ORAL 203802 ANDA Mylan Pharmaceuticals Inc. 0378-3978 0378-3978-93 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3978-93)
PALIPERIDONE
paliperidone
TABLET, EXTENDED RELEASE;ORAL 203802 ANDA Mylan Pharmaceuticals Inc. 0378-3979 0378-3979-93 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3979-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1.5MG
Approval Date:Sep 24, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength3MG
Approval Date:Sep 24, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength6MG
Approval Date:Sep 24, 2015TE:ABRLD: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.

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