Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 089560
Company: CHARTWELL RX

Products on ANDA 089560

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089560

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/18/1988	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
11/08/1989	SUPPL-30	Labeling		Label is not available on this site.
05/20/2003	SUPPL-19	Labeling		Label is not available on this site.
01/24/2003	SUPPL-18	Labeling		Label is not available on this site.
02/19/1999	SUPPL-12	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/02/1999	SUPPL-11	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/16/1996	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/08/1995	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
05/17/1993	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
11/08/1989	SUPPL-3	Labeling		Label is not available on this site.
05/09/1989	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/09/1989	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 089560

SULFACETAMIDE SODIUM

SOLUTION/DROPS;OPHTHALMIC; 10%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	040066	BAUSCH AND LOMB
SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	089560	CHARTWELL RX