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Details for New Drug Application (NDA): 021222

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NDA 021222 describes SPECTRACEF, which is a drug marketed by Vansen Pharma and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the SPECTRACEF profile page.

The generic ingredient in SPECTRACEF is cefditoren pivoxil. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cefditoren pivoxil profile page.

Summary for NDA: 021222

Tradename:
SPECTRACEF
Applicant:
Vansen Pharma
Ingredient:
cefditoren pivoxil
Patents:1
Therapeutic Class:Antibacterials

Pharmacology for NDA: 021222

Ingredient-typeCephalosporins

Suppliers and Packaging for NDA: 021222

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPECTRACEF
cefditoren pivoxil
TABLET;ORAL 021222 NDA Vansen Pharma Inc. 44004-801 44004-801-20 20 TABLET, FILM COATED in 1 BLISTER PACK (44004-801-20)
SPECTRACEF
cefditoren pivoxil
TABLET;ORAL 021222 NDA Vansen Pharma Inc. 44004-802 44004-802-20 20 TABLET, FILM COATED in 1 BLISTER PACK (44004-802-20)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG
Approval Date:Aug 29, 2001TE:RLD:No
Patent:5,958,915Patent Expiration:Oct 14, 2016Product Flag?Substance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength400MG
Approval Date:Jul 21, 2008TE:RLD:No
Patent:5,958,915Patent Expiration:Oct 14, 2016Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021222

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Vansen Pharma
SPECTRACEF
cefditoren pivoxil
TABLET;ORAL021222-001Aug 29, 20014,839,350► subscribe
Vansen Pharma
SPECTRACEF
cefditoren pivoxil
TABLET;ORAL021222-002Jul 21, 20085,958,915► subscribe
Vansen Pharma
SPECTRACEF
cefditoren pivoxil
TABLET;ORAL021222-002Jul 21, 20084,839,350► subscribe
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