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Details for New Drug Application (NDA): 091589

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NDA 091589 describes TOBRAMYCIN, which is a drug marketed by Amneal Pharms, Akorn Inc, Fera Pharms, Bausch And Lomb, Alcon Pharms Ltd, Apotex Inc, Teva Pharms Usa, Mylan Labs Ltd, Hospira, West-ward Pharms Int, X Gen Pharms, Igi Labs Inc, Apothecon, Fresenius Kabi Usa, Watson Labs Inc, Claris, Akorn, and Xellia Pharms Aps, and is included in thirty-five NDAs. It is available from fourteen suppliers. Additional details are available on the TOBRAMYCIN profile page.

The generic ingredient in TOBRAMYCIN is tobramycin sulfate. There are eighteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.

Summary for NDA: 091589

Tradename:
TOBRAMYCIN
Applicant:
Teva Pharms Usa
Ingredient:
tobramycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 091589

Ingredient-typeAminoglycosides

Suppliers and Packaging for NDA: 091589

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRAMYCIN
tobramycin
SOLUTION;INHALATION 091589 ANDA Teva Pharmaceuticals USA Inc 0093-4085 0093-4085-63 56 AMPULE in 1 CARTON (0093-4085-63) > 5 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength300MG/5ML
Approval Date:Oct 10, 2013TE:ANRLD:No


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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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