Details for New Drug Application (NDA): 212715
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NDA 212715 describes TOBRAMYCIN AND DEXAMETHASONE, which is a drug marketed by Amneal, Bausch And Lomb, and Padagis Us, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the TOBRAMYCIN AND DEXAMETHASONE profile page.
The generic ingredient in TOBRAMYCIN AND DEXAMETHASONE is dexamethasone; tobramycin. There are thirty-nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dexamethasone; tobramycin profile page.
The generic ingredient in TOBRAMYCIN AND DEXAMETHASONE is dexamethasone; tobramycin. There are thirty-nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dexamethasone; tobramycin profile page.
Summary for 212715
| Tradename: | TOBRAMYCIN AND DEXAMETHASONE |
| Applicant: | Padagis Us |
| Ingredient: | dexamethasone; tobramycin |
| Patents: | 0 |
Pharmacology for NDA: 212715
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 212715
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOBRAMYCIN AND DEXAMETHASONE | dexamethasone; tobramycin | SUSPENSION/DROPS;OPHTHALMIC | 212715 | ANDA | Padagis US LLC | 0574-4031 | 0574-4031-05 | 5 mL in 1 BOTTLE, PLASTIC (0574-4031-05) |
| TOBRAMYCIN AND DEXAMETHASONE | dexamethasone; tobramycin | SUSPENSION/DROPS;OPHTHALMIC | 212715 | ANDA | Padagis US LLC | 0574-4031 | 0574-4031-10 | 10 mL in 1 BOTTLE, PLASTIC (0574-4031-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.1%;0.3% | ||||
| Approval Date: | Feb 11, 2022 | TE: | AB | RLD: | No | ||||
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