Details for New Drug Application (NDA): 217029
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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 217029
Tradename: | TOBRAMYCIN SULFATE |
Applicant: | Hainan Poly |
Ingredient: | tobramycin sulfate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 217029
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 217029 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-110 | 70436-110-36 | 30 mL in 1 VIAL (70436-110-36) |
TOBRAMYCIN SULFATE | tobramycin sulfate | INJECTABLE;INJECTION | 217029 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-110 | 70436-110-56 | 180 mL in 1 CARTON (70436-110-56) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 1.2GM BASE/VIAL | ||||
Approval Date: | Feb 1, 2023 | TE: | AP | RLD: | No |
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