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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063117
Company: HIKMA

Products on ANDA 063117

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 063117

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/1991	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/26/2002	SUPPL-8	Labeling		Label is not available on this site.
07/23/2001	SUPPL-7	Labeling		Label is not available on this site.
08/30/2000	SUPPL-6	Labeling		Label is not available on this site.
04/25/2000	SUPPL-5	Labeling		Label is not available on this site.
09/13/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/28/1994	SUPPL-3	Labeling		Label is not available on this site.
08/17/1994	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/27/1993	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 063117

TOBRAMYCIN SULFATE

INJECTABLE;INJECTION; EQ 40MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	206965	BAXTER HLTHCARE CORP
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	065122	FRESENIUS KABI USA
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	209621	GLAND PHARMA LTD
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	063117	HIKMA
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	063111	HOSPIRA
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	065407	MYLAN LABS LTD
TOBRAMYCIN SULFATE (PHARMACY BULK)	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	065120	FRESENIUS KABI USA
TOBRAMYCIN SULFATE (PHARMACY BULK)	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	209346	GLAND PHARMA LTD

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