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Details for New Drug Application (NDA): 201688

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NDA 201688 describes TOBI PODHALER, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are eight 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the tobramycin profile page.

Summary for NDA: 201688

Tradename:
TOBI PODHALER
Applicant:
Novartis
Ingredient:
tobramycin
Patents:8
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 201688

Ingredient-typeAminoglycosides

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 Novartis Pharmaceuticals Corporation 0078-0630 0078-0630-19 8 CAPSULE in 1 BOX, UNIT-DOSE (0078-0630-19)
TOBI PODHALER
tobramycin
POWDER;INHALATION 201688 NDA Novartis Pharmaceuticals Corporation 0078-0630 0078-0630-20 56 CAPSULE in 1 BOX, UNIT-DOSE (0078-0630-20)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength28MG
Approval Date:Mar 22, 2013TE:RLD:Yes
Patent:7,097,827Patent Expiration:Apr 16, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:7,442,388Patent Expiration:May 10, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:7,516,741Patent Expiration:Jan 11, 2024Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 201688

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
TOBI PODHALER
tobramycin
POWDER;INHALATION201688-001Mar 22, 20137,097,827► subscribe
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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 verifification 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.

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