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Details for New Drug Application (NDA): 050753
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The generic ingredient in TOBI 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 050753
Tradename: | TOBI |
Applicant: | Mylan Speciality Lp |
Ingredient: | tobramycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 050753
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOBI | tobramycin | SOLUTION;INHALATION | 050753 | NDA | Novartis Pharmaceuticals Corporation | 0078-0494 | 0078-0494-71 | 56 POUCH in 1 CARTON (0078-0494-71) > 4 AMPULE in 1 POUCH (0078-0494-91) > 5 mL in 1 AMPULE (0078-0494-61) |
TOBI | tobramycin | SOLUTION;INHALATION | 050753 | NDA AUTHORIZED GENERIC | Sandoz Inc | 0781-7171 | 0781-7171-56 | 56 AMPULE in 1 CARTON (0781-7171-56) > 5 mL in 1 AMPULE (0781-7171-75) |
Paragraph IV (Patent) Challenges for 050753
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
TOBI | SOLUTION;INHALATION | tobramycin | 050753 | 2009-06-29 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 300MG/5ML | ||||
Approval Date: | Dec 22, 1997 | TE: | AN | RLD: | Yes |
Expired US Patents for NDA 050753
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mylan Speciality Lp | TOBI | tobramycin | SOLUTION;INHALATION | 050753-001 | Dec 22, 1997 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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