Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Boehringer Ingelheim
Harvard Business School
Colorcon
Medtronic

Last Updated: December 3, 2022

Details for New Drug Application (NDA): 201688


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 ten 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-four 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:10
Formulation / Manufacturing:see details
Pharmacology for NDA: 201688
Medical Subject Heading (MeSH) Categories for 201688
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. 49502-346 49502-346-24 224 PACKAGE in 1 BOX, UNIT-DOSE (49502-346-24) > 56 BLISTER PACK in 1 PACKAGE > 4 CAPSULE in 1 BLISTER PACK
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength28MG
Approval Date:Mar 22, 2013TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Nov 4, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
Patent:See Plans and PricingPatent Expiration:Dec 19, 2022Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
Patent:See Plans and PricingPatent Expiration:Jan 11, 2024Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 201688

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Medtronic
Moodys
Colorcon
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.