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Generated: April 29, 2017

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Details for New Drug Application (NDA): 204945

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NDA 204945 describes TROSPIUM CHLORIDE, which is a drug marketed by Apotex, Upsher-smith Labs, Heritage Pharms Inc, Paddock Llc, Glenmark Generics, Invagen Pharms, and Actavis Labs Fl Inc, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the TROSPIUM CHLORIDE profile page.

The generic ingredient in TROSPIUM CHLORIDE is trospium chloride. There are sixteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the trospium chloride profile page.

Summary for NDA: 204945

Therapeutic Class:Genitourinary Agents

Pharmacology for NDA: 204945

Suppliers and Packaging for NDA: 204945

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
trospium chloride
TABLET;ORAL 204945 ANDA Heritage Pharmaceuticals Inc. 23155-530 23155-530-02 200 TABLET, FILM COATED in 1 BOTTLE (23155-530-02)
trospium chloride
TABLET;ORAL 204945 ANDA Heritage Pharmaceuticals Inc. 23155-530 23155-530-05 500 TABLET, FILM COATED in 1 BOTTLE (23155-530-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Aug 30, 2016TE:ABRLD:No

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