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Details for New Drug Application (NDA): 064134

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NDA 064134 describes TOBRAMYCIN AND DEXAMETHASONE, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from four 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-eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the dexamethasone; tobramycin profile page.

Summary for NDA: 064134

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 064134

Suppliers and Packaging for NDA: 064134

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRAMYCIN AND DEXAMETHASONE
dexamethasone; tobramycin
SUSPENSION/DROPS;OPHTHALMIC 064134 ANDA Bausch & Lomb Incorporated 24208-295 24208-295-05 1 BOTTLE, DROPPER in 1 CARTON (24208-295-05) > 5 mL in 1 BOTTLE, DROPPER
TOBRAMYCIN AND DEXAMETHASONE
dexamethasone; tobramycin
SUSPENSION/DROPS;OPHTHALMIC 064134 ANDA Bausch & Lomb Incorporated 24208-295 24208-295-10 1 BOTTLE, DROPPER in 1 CARTON (24208-295-10) > 10 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.1%;0.3%
Approval Date:Oct 27, 1999TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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