Details for New Drug Application (NDA): 201688

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NDA 201688 describes TOBI PODHALER, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the TOBI PODHALER profile page.

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

Summary for 201688

Tradename:	TOBI PODHALER
Applicant:	Mylan Speciality Lp
Ingredient:	tobramycin
Patents:	7

Pharmacology for NDA: 201688

Medical Subject Heading (MeSH) Categories for 201688

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 201688

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOBI PODHALER	tobramycin	POWDER;INHALATION	201688	NDA	Mylan Specialty L.P.	49502-401	49502-401-09	8 CAPSULE in 1 BOX, UNIT-DOSE (49502-401-09)
TOBI PODHALER	tobramycin	POWDER;INHALATION	201688	NDA	Mylan Specialty L.P.	49502-401	49502-401-24	224 PACKAGE in 1 BOX, UNIT-DOSE (49502-401-24) / 56 BLISTER PACK in 1 PACKAGE / 4 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INHALATION			Strength	28MG
Approval Date:	Mar 22, 2013	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 4, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
Patent:	⤷ Sign Up	Patent Expiration:	Nov 7, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
Patent:	⤷ Sign Up	Patent Expiration:	Jan 11, 2024	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 201688

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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