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Details for New Drug Application (NDA): 040587

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NDA 040587 describes BENZONATATE, which is a drug marketed by Thepharmanetwork Llc, Apotex Inc, The Pharma Network, Strides Pharma, Mikart, Cspc Nbp Pharm Co, Orit Labs Llc, Sun Pharm Inds Inc, Nesher Pharms, Bionpharma Inc, and Zydus Pharms Usa, and is included in twelve NDAs. It is available from forty-nine suppliers. Additional details are available on the BENZONATATE profile page.

The generic ingredient in BENZONATATE is benzonatate. There are six drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the benzonatate profile page.

Summary for NDA: 040587

Tradename:
BENZONATATE
Applicant:
Sun Pharm Inds Inc
Ingredient:
benzonatate
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040587

Suppliers and Packaging for NDA: 040587

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZONATATE
benzonatate
CAPSULE;ORAL 040587 ANDA Northwind Pharmaceuticals 51655-771 51655-771-20 20 CAPSULE in 1 BOTTLE, DISPENSING (51655-771-20)
BENZONATATE
benzonatate
CAPSULE;ORAL 040587 ANDA Northwind Pharmaceuticals 51655-771 51655-771-52 30 CAPSULE in 1 BOTTLE, DISPENSING (51655-771-52)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Mar 19, 2008TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Mar 19, 2008TE:AARLD:No


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