Details for New Drug Application (NDA): 209621
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NDA 209621 describes TOBRAMYCIN SULFATE, which is a drug marketed by Apothecon, Baxter Hlthcare Corp, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Hospira, Igi Labs Inc, Mylan Labs Ltd, Slate Run Pharma, Teva Pharms Usa, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms, and is included in thirty-two NDAs. It is available from eleven suppliers. Additional details are available on the TOBRAMYCIN SULFATE profile page.
The generic ingredient in TOBRAMYCIN SULFATE 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 SULFATE 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 209621
| Tradename: | TOBRAMYCIN SULFATE |
| Applicant: | Gland |
| Ingredient: | tobramycin sulfate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209621
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 209621 | ANDA | Gland Pharma Limited | 68083-253 | 68083-253-25 | 25 VIAL, MULTI-DOSE in 1 CARTON (68083-253-25) / 2 mL in 1 VIAL, MULTI-DOSE (68083-253-01) |
| TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 209621 | ANDA | Gland Pharma Limited | 68083-254 | 68083-254-25 | 25 VIAL, MULTI-DOSE in 1 CARTON (68083-254-25) / 2 mL in 1 VIAL, MULTI-DOSE (68083-254-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 10MG BASE/ML | ||||
| Approval Date: | Feb 11, 2021 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 40MG BASE/ML | ||||
| Approval Date: | Feb 11, 2021 | TE: | AP | RLD: | No | ||||
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