Details for New Drug Application (NDA): 212991
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NDA 212991 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 eight 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 212991
| Tradename: | TOBRAMYCIN AND DEXAMETHASONE |
| Applicant: | Amneal |
| Ingredient: | dexamethasone; tobramycin |
| Patents: | 0 |
Pharmacology for NDA: 212991
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 212991
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOBRAMYCIN AND DEXAMETHASONE | dexamethasone; tobramycin | SUSPENSION/DROPS;OPHTHALMIC | 212991 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1373 | 69238-1373-2 | 1 BOTTLE, PLASTIC in 1 CARTON (69238-1373-2) / 2.5 mL in 1 BOTTLE, PLASTIC |
| TOBRAMYCIN AND DEXAMETHASONE | dexamethasone; tobramycin | SUSPENSION/DROPS;OPHTHALMIC | 212991 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1374 | 69238-1374-3 | 1 BOTTLE, PLASTIC in 1 CARTON (69238-1374-3) / 5 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SUSPENSION/DROPS;OPHTHALMIC | Strength | 0.1%;0.3% | ||||
| Approval Date: | Jul 15, 2021 | TE: | RLD: | No | |||||
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