Details for New Drug Application (NDA): 205501
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NDA 205501 describes TOBRAMYCIN, which is a drug marketed by Alcon Pharms Ltd, Alembic, Apotex Inc, Bausch And Lomb, Chartwell Rx, Gland Pharma Ltd, Somerset Theraps Llc, Alkem Labs Ltd, Amneal Pharms, Dr Reddys Labs Sa, Hikma, Luoxin Aurovitas, Lupin, Mankind Pharma, Micro Labs, Norvium Bioscience, Sun Pharm, Teva Pharms Usa, Amneal, Padagis Us, Apothecon, Baxter Hlthcare Corp, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Mylan Labs Ltd, Slate Run Pharma, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms, and is included in fifty-five NDAs. It is available from thirty 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. Eleven suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.
The generic ingredient in TOBRAMYCIN is tobramycin sulfate. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.
Summary for 205501
| Tradename: | TOBRAMYCIN |
| Applicant: | Amneal Pharms |
| Ingredient: | tobramycin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205501
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOBRAMYCIN | tobramycin | SOLUTION;INHALATION | 205501 | ANDA | Amneal Pharmaceuticals LLC | 65162-914 | 65162-914-46 | 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 300MG/5ML | ||||
| Approval Date: | Jul 13, 2015 | TE: | AN | RLD: | No | ||||
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