Details for New Drug Application (NDA): 050753

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NDA 050753 describes TOBI, which is a drug marketed by Mylan Speciality Lp and is included in two NDAs. It is available from two suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TOBI profile page.

The generic ingredient in TOBI is tobramycin. There are eighteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the tobramycin profile page.

Summary for 050753

Tradename:	TOBI
Applicant:	Mylan Speciality Lp
Ingredient:	tobramycin
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 050753

Medical Subject Heading (MeSH) Categories for 050753

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 050753

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOBI	tobramycin	SOLUTION;INHALATION	050753	NDA	Novartis Pharmaceuticals Corporation	0078-0494	0078-0494-71	56 POUCH in 1 CARTON (0078-0494-71) > 4 AMPULE in 1 POUCH (0078-0494-91) > 5 mL in 1 AMPULE (0078-0494-61)
TOBI	tobramycin	SOLUTION;INHALATION	050753	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-7171	0781-7171-56	56 AMPULE in 1 CARTON (0781-7171-56) > 5 mL in 1 AMPULE (0781-7171-75)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	300MG/5ML
Approval Date:	Dec 22, 1997	TE:	AN	RLD:	Yes

Expired US Patents for NDA 050753

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	TOBI	tobramycin	SOLUTION;INHALATION	050753-001	Dec 22, 1997	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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