Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018604
Company: BAUSCH

Products on NDA 018604

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOVIRAX	ACYCLOVIR	5%	OINTMENT;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018604

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/1982	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/29/2014	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
11/22/2002	SUPPL-19	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/018604Orig1s019ltr.pdf
05/30/2001	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018604s018lbl.pdf
07/12/2000	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
05/30/2001	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018604s018lbl.pdf
02/03/1999	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
01/08/1997	SUPPL-14	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018604S014.pdf
10/29/1996	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
11/09/1993	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
01/21/1993	SUPPL-10	Labeling		Label is not available on this site.
07/23/1992	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
01/21/1993	SUPPL-8	Labeling		Label is not available on this site.
11/12/1986	SUPPL-7	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
04/02/1985	SUPPL-6	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
12/16/1982	SUPPL-4	Labeling		Label is not available on this site.
07/21/1982	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
06/14/1982	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.

Labels for NDA 018604

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/30/2001	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018604s018lbl.pdf
05/30/2001	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018604s018lbl.pdf

Therapeutic Equivalents for NDA 018604

ZOVIRAX

OINTMENT;TOPICAL; 5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACYCLOVIR	ACYCLOVIR	5%	OINTMENT;TOPICAL	Prescription	No	AB	209000	ALEMBIC
ACYCLOVIR	ACYCLOVIR	5%	OINTMENT;TOPICAL	Prescription	No	AB	204605	AMNEAL PHARMS
ACYCLOVIR	ACYCLOVIR	5%	OINTMENT;TOPICAL	Prescription	No	AB	212495	CHARTWELL RX
ACYCLOVIR	ACYCLOVIR	5%	OINTMENT;TOPICAL	Prescription	No	AB	206633	FOUGERA PHARMS INC
ACYCLOVIR	ACYCLOVIR	5%	OINTMENT;TOPICAL	Prescription	No	AB	205510	GLENMARK SPECLT
ACYCLOVIR	ACYCLOVIR	5%	OINTMENT;TOPICAL	Prescription	No	AB	212444	MACLEODS PHARMS LTD
ACYCLOVIR	ACYCLOVIR	5%	OINTMENT;TOPICAL	Prescription	No	AB	202459	PHARMOBEDIENT
ACYCLOVIR	ACYCLOVIR	5%	OINTMENT;TOPICAL	Prescription	No	AB	205469	SUN PHARMA CANADA
ACYCLOVIR	ACYCLOVIR	5%	OINTMENT;TOPICAL	Prescription	No	AB	209971	TORRENT
ACYCLOVIR	ACYCLOVIR	5%	OINTMENT;TOPICAL	Prescription	No	AB	201501	XIROMED
ACYCLOVIR	ACYCLOVIR	5%	OINTMENT;TOPICAL	Prescription	No	AB	205974	ZYDUS LIFESCIENCES
ZOVIRAX	ACYCLOVIR	5%	OINTMENT;TOPICAL	Prescription	Yes	AB	018604	BAUSCH