An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 064067
Company: BAUSCH AND LOMB

Products on ANDA 064067

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ERYTHROMYCIN	ERYTHROMYCIN	0.5%	OINTMENT;OPHTHALMIC	Prescription	AT	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064067

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/1994	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
08/20/2002	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/05/2002	SUPPL-15	Manufacturing (CMC)-Facility		Label is not available on this site.
11/27/2001	SUPPL-14	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/07/2001	SUPPL-13	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/27/2000	SUPPL-12	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/01/2000	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
06/07/1999	SUPPL-9	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/31/1999	SUPPL-8	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/31/1999	SUPPL-7	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/04/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/22/1998	SUPPL-5	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/21/1997	SUPPL-4	Labeling		Label is not available on this site.
01/31/1996	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/24/1996	SUPPL-2	Labeling		Label is not available on this site.
02/01/1995	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 064067

ERYTHROMYCIN

OINTMENT;OPHTHALMIC; 0.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ERYTHROMYCIN	ERYTHROMYCIN	0.5%	OINTMENT;OPHTHALMIC	Prescription	No	AT	064067	BAUSCH AND LOMB
ERYTHROMYCIN	ERYTHROMYCIN	0.5%	OINTMENT;OPHTHALMIC	Prescription	No	AT	064030	SENTISS

Top