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Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064052

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NDA 064052 describes TOBRAMYCIN, which is a drug marketed by Amneal Pharms, Akorn Inc, Fera Pharms, Somerset Theraps Llc, Bausch And Lomb, Lupin Atlantis, 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-seven NDAs. It is available from fifteen 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: 064052

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 064052

Ingredient-typeAminoglycosides

Suppliers and Packaging for NDA: 064052

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRAMYCIN
tobramycin
SOLUTION/DROPS;OPHTHALMIC 064052 ANDA Major Pharmaceuticals 0904-2970 0904-2970-05 1 BOTTLE, DROPPER in 1 CARTON (0904-2970-05) > 5 mL in 1 BOTTLE, DROPPER
TOBRAMYCIN
tobramycin
SOLUTION/DROPS;OPHTHALMIC 064052 ANDA MWI 13985-743 13985-743-05 1 BOTTLE, DROPPER in 1 CARTON (13985-743-05) > 5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.3%
Approval Date:Nov 29, 1993TE:ATRLD:No


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Serving 500+ biopharmaceutical companies globally:

Merck
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Mallinckrodt
Queensland Health
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Daiichi Sankyo
Express Scripts
UBS

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