Details for New Drug Application (NDA): 207080
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The generic ingredient in TOBRAMYCIN is tobramycin sulfate. There are eighteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.
Summary for 207080
Tradename: | TOBRAMYCIN |
Applicant: | Dr Reddys Labs Sa |
Ingredient: | tobramycin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207080
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TOBRAMYCIN | tobramycin | SOLUTION;INHALATION | 207080 | ANDA | NorthStar RxLLC | 16714-119 | 16714-119-03 | 14 POUCH in 1 CARTON (16714-119-03) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE (16714-119-02) |
TOBRAMYCIN | tobramycin | SOLUTION;INHALATION | 207080 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-605 | 43598-605-56 | 14 POUCH in 1 CARTON (43598-605-56) / 4 AMPULE in 1 POUCH (43598-605-04) / 5 mL in 1 AMPULE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INHALATION | Strength | 300MG/5ML | ||||
Approval Date: | Jul 9, 2018 | TE: | AN | RLD: | No |
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