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Details for New Drug Application (NDA): 050753
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NDA 050753 describes TOBI, which is a drug marketed by Mylan Speciality Lp and is included in two NDAs. It is available from two suppliers. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TOBI profile page.
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.
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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