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Generated: April 18, 2019

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Details for New Drug Application (NDA): 040268

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NDA 040268 describes PROCOMP, which is a drug marketed by Jubilant Cadista and is included in one NDA. It is available from sixteen suppliers. Additional details are available on the PROCOMP profile page.

The generic ingredient in PROCOMP is prochlorperazine maleate. There are twenty-one drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the prochlorperazine maleate profile page.
Summary for 040268
Applicant:Jubilant Cadista
Ingredient:prochlorperazine maleate
Formulation / Manufacturing:see details
Pharmacology for NDA: 040268
Suppliers and Packaging for NDA: 040268
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROCOMP prochlorperazine maleate TABLET;ORAL 040268 ANDA Liberty Pharmaceuticals, Inc. 0440-8190 0440-8190-12 12 TABLET in 1 BOTTLE, PLASTIC (0440-8190-12)
PROCOMP prochlorperazine maleate TABLET;ORAL 040268 ANDA Blenheim Pharmacal, Inc. 10544-281 10544-281-30 30 TABLET in 1 BOTTLE (10544-281-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Feb 27, 1998TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Feb 27, 1998TE:ABRLD:No

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