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Last Updated: November 4, 2024

TOBRAMYCIN SULFATE - Generic Drug Details


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What are the generic drug sources for tobramycin sulfate and what is the scope of freedom to operate?

Tobramycin sulfate is the generic ingredient in four branded drugs marketed by Lilly, Apothecon, Baxter Hlthcare Corp, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, 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-six NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for tobramycin sulfate. Eleven suppliers are listed for this compound.

Summary for TOBRAMYCIN SULFATE
US Patents:0
Tradenames:4
Applicants:16
NDAs:36
Drug Master File Entries: 4
Finished Product Suppliers / Packagers: 11
Raw Ingredient (Bulk) Api Vendors: 105
Clinical Trials: 5
Patent Applications: 6,764
What excipients (inactive ingredients) are in TOBRAMYCIN SULFATE?TOBRAMYCIN SULFATE excipients list
DailyMed Link:TOBRAMYCIN SULFATE at DailyMed
Recent Clinical Trials for TOBRAMYCIN SULFATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Madonna Magdy FahmyEarly Phase 1
Joint Purification SystemsPhase 2
Osteal Therapeutics, Inc.Phase 2

See all TOBRAMYCIN SULFATE clinical trials

Pharmacology for TOBRAMYCIN SULFATE

US Patents and Regulatory Information for TOBRAMYCIN SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Xgen Pharms TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 065013-001 Aug 17, 2001 AP RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 063112-001 Apr 30, 1991 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER tobramycin sulfate INJECTABLE;INJECTION 063081-003 Jul 31, 1990 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 065122-001 Nov 29, 2002 AP RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa TOBRAMYCIN SULFATE tobramycin sulfate INJECTABLE;INJECTION 065122-002 Nov 29, 2002 AP RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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