Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064048
Company: BAUSCH AND LOMB

Products on ANDA 064048

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064048

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/1994	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
11/27/2001	SUPPL-14	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/29/2001	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/07/2001	SUPPL-12	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/05/2000	SUPPL-11	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/27/2000	SUPPL-10	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/15/2000	SUPPL-9	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/28/2000	SUPPL-8	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/18/2000	SUPPL-7	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/07/1999	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
11/19/1998	SUPPL-5	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/04/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/14/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/26/1996	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
09/09/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 064048

GENTAMICIN SULFATE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.3% BASE
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	064048	BAUSCH AND LOMB
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	065121	PADAGIS US
GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	062196	SANDOZ