Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 063100
Company: TEVA PHARMS USA
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/30/1992 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
12/09/2010 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

08/09/2000 SUPPL-7 Labeling

Label is not available on this site.

07/13/1999 SUPPL-6 Labeling

Label is not available on this site.

06/02/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/16/1993 SUPPL-4 Labeling

Label is not available on this site.

04/04/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/02/1993 SUPPL-2 Labeling

Label is not available on this site.

03/10/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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 205179 AKORN
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 063111 HOSPIRA
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE;INJECTION Prescription No AP 065407 MYLAN LABS LTD
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE;INJECTION Prescription No AP 063100 TEVA PHARMS USA
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE;INJECTION Prescription No AP 063117 WEST-WARD PHARMS INT

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