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Approved Drug Products containing Tobramycin listed in the FDA Orange Book. Original Data : FDA Website

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01 1DR REDDYS LABS SA

02 1ALCON PHARMS LTD

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07 1APOTEX INC

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16 1LUPIN

17 2MANKIND PHARMA

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21 3NOVARTIS

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code : AN

TOBRAMYCIN

Brand Name : TOBRAMYCIN

Dosage Form : SOLUTION;INHALATION

Dosage Strength : 300MG/5ML

Approval Date : 2018-07-09

Application Number : 207080

RX/OTC/DISCN : RX

RLD : No

TE Code : AN

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02

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LOTEPREDNOL ETABONATE; TOBRAMYCIN

Brand Name : ZYLET

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.5%;0.3%

Approval Date : 2004-12-14

Application Number : 50804

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

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FLUOROMETHOLONE ACETATE; TOBRAMYCIN

Brand Name : TOBRASONE

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.1%;0.3%

Approval Date : 1989-07-21

Application Number : 50628

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

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DEXAMETHASONE; TOBRAMYCIN

Brand Name : TOBRADEX ST

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.05%;0.3%

Approval Date : 2009-02-13

Application Number : 50818

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

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TOBRAMYCIN

Brand Name : TOBREX

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.3%

Approval Date : 1982-01-01

Application Number : 50541

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

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TOBRAMYCIN

Brand Name : TOBREX

Dosage Form : OINTMENT;OPHTHALMIC

Dosage Strength : 0.3%

Approval Date : 1982-01-01

Application Number : 50555

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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07

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DEXAMETHASONE; TOBRAMYCIN

Brand Name : TOBRADEX

Dosage Form : OINTMENT;OPHTHALMIC

Dosage Strength : 0.1%;0.3%

Approval Date : 1988-09-28

Application Number : 50616

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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08

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DEXAMETHASONE; TOBRAMYCIN

Brand Name : TOBRADEX

Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

Dosage Strength : 0.1%;0.3%

Approval Date : 1988-08-18

Application Number : 50592

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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09

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TOBRAMYCIN

Brand Name : TOBREX

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : 0.3%

Approval Date : 1984-12-13

Application Number : 62535

RX/OTC/DISCN : RX

RLD : No

TE Code : AT

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10

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TOBRAMYCIN

Brand Name : TOBI

Dosage Form : SOLUTION;INHALATION

Dosage Strength : 300MG/5ML

Approval Date : 1997-12-22

Application Number : 50753

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AN

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