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Details for New Drug Application (NDA): 021821

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NDA 021821 describes TYGACIL, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TYGACIL profile page.

The generic ingredient in TYGACIL is tigecycline. There are ten drug master file entries for this compound. One supplier is listed for this compound. There are two tentative approvals for this compound. Additional details are available on the tigecycline profile page.

Summary for NDA: 021821

Tradename:
TYGACIL
Applicant:
Pf Prism Cv
Ingredient:
tigecycline
Patents:5
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 021821

Ingredient-typeTetracyclines

Suppliers and Packaging for NDA: 021821

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TYGACIL
tigecycline
INJECTABLE;IV (INFUSION) 021821 NDA Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 0008-4990 0008-4990-02 10 VIAL, SINGLE-USE in 1 CARTON (0008-4990-02) > 50 mL in 1 VIAL, SINGLE-USE (0008-4990-01)
TYGACIL
tigecycline
INJECTABLE;IV (INFUSION) 021821 NDA Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. 0008-4990 0008-4990-20 10 VIAL, SINGLE-USE in 1 CARTON (0008-4990-20) > 50 mL in 1 VIAL, SINGLE-USE (0008-4990-19)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/VIAL
Approval Date:Jun 15, 2005TE:APRLD:Yes
Patent:7,879,828Patent Expiration:Feb 5, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:8,372,995Patent Expiration:Oct 8, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:8,975,242Patent Expiration:Oct 24, 2028Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021821

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
TYGACIL
tigecycline
INJECTABLE;IV (INFUSION)021821-001Jun 15, 20055,494,903► subscribe
Pf Prism Cv
TYGACIL
tigecycline
INJECTABLE;IV (INFUSION)021821-001Jun 15, 2005RE40183► subscribe
Pf Prism Cv
TYGACIL
tigecycline
INJECTABLE;IV (INFUSION)021821-001Jun 15, 2005RE40086► subscribe
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