Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018604
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOVIRAX ACYCLOVIR 5% OINTMENT;TOPICAL Prescription AB Yes Yes
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.

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

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 205591 ACP NIMBLE
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 209000 ALEMBIC PHARMS LTD
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 204605 AMNEAL PHARMS
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 211794 CIPLA
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 206633 FOUGERA PHARMS INC
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 205510 GLENMARK PHARMS SA
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 202459 MYLAN PHARMS INC
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 205659 PERRIGO UK FINCO
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 205469 TARO
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 206437 TOLMAR
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 209971 TORRENT
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 205974 ZYDUS PHARMS
ZOVIRAX ACYCLOVIR 5% OINTMENT;TOPICAL Prescription Yes AB 018604 BAUSCH

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