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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062945
Company: WATSON LABS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE;INJECTION Discontinued None 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
08/09/1989 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
02/10/2023 SUPPL-22 Labeling-Package Insert

Label is not available on this site.
02/10/2023 SUPPL-21 Labeling-Package Insert

Label is not available on this site.
02/10/2023 SUPPL-20 Labeling-Package Insert

Label is not available on this site.
02/10/2023 SUPPL-19 Labeling-Package Insert

Label is not available on this site.
12/08/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
06/20/2000 SUPPL-16 Labeling

Label is not available on this site.
04/28/2000 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
11/03/1998 SUPPL-14 Labeling

Label is not available on this site.
07/11/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
11/01/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
10/27/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.
06/17/1994 SUPPL-10 Labeling

Label is not available on this site.
03/15/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
04/10/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
03/05/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
04/29/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
04/13/1992 SUPPL-5 Labeling

Label is not available on this site.
05/31/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
05/10/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
04/13/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.
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