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Last Updated: April 23, 2024

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 six 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. Eight suppliers are listed for this compound. Additional details are available on the tigecycline profile page.
Summary for 021821
Tradename:TYGACIL
Applicant:Pf Prism Cv
Ingredient:tigecycline
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 021821
Suppliers and Packaging for NDA: 021821
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TYGACIL tigecycline POWDER;INTRAVENOUS 021821 NDA Wyeth Pharmaceuticals LLC, 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)
TYGACIL tigecycline POWDER;INTRAVENOUS 021821 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0008-4994 0008-4994-20 10 VIAL, SINGLE-USE in 1 CARTON (0008-4994-20) / 50 mL in 1 VIAL, SINGLE-USE (0008-4994-19)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength50MG/VIAL
Approval Date:Jun 15, 2005TE:APRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Mar 13, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Feb 5, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Oct 8, 2030Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021821

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 ⤷  Try a Trial ⤷  Try a Trial
Pf Prism Cv TYGACIL tigecycline POWDER;INTRAVENOUS 021821-001 Jun 15, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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