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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 fifteen suppliers. Additional details are available on the PROCOMP profile page.

The generic ingredient in PROCOMP is prochlorperazine maleate. There are eighteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the prochlorperazine maleate profile page.

Summary for NDA: 040268

Therapeutic Class:Antiemetics
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
prochlorperazine maleate
TABLET;ORAL 040268 ANDA Liberty Pharmaceuticals, Inc. 0440-8190 0440-8190-12 12 TABLET in 1 BOTTLE, PLASTIC (0440-8190-12)
prochlorperazine maleate
TABLET;ORAL 040268 ANDA Blenheim Pharmacal, Inc. 10544-281 10544-281-30 30 TABLET in 1 BOTTLE (10544-281-30)

Summary for product number 001

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

Summary for product number 002

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

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