Details for New Drug Application (NDA): 205433
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NDA 205433 describes KITABIS PAK, which is a drug marketed by Pulmoflow Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the KITABIS PAK profile page.
The generic ingredient in KITABIS PAK is tobramycin. There are eighteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
The generic ingredient in KITABIS PAK is tobramycin. There are eighteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
Summary for 205433
| Tradename: | KITABIS PAK |
| Applicant: | Pulmoflow Inc |
| Ingredient: | tobramycin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205433
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KITABIS PAK | tobramycin | SOLUTION;INHALATION | 205433 | NDA | Pari Respiratory Equipment, Inc. | 24492-850 | 24492-850-56 | 14 POUCH in 1 CARTON (24492-850-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
| KITABIS PAK | tobramycin | SOLUTION;INHALATION | 205433 | NDA AUTHORIZED GENERIC | Genericus, Inc. | 70644-899 | 70644-899-99 | 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 300MG/5ML | ||||
| Approval Date: | Dec 2, 2014 | TE: | AN | RLD: | No | ||||
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