Acyclovir Topical Ointment

Brand(s)
Zovirax
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Valeant Pharmaceuticals North America Llc (2014-11-20)
Oldest Current Product
1982-03-29
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
TOPICAL OINTMENT\ACYCLOVIR
FDAOB
TOPICAL\OINTMENT\ACYCLOVIR
SPL Active
TOPICAL\OINTMENT\ACYCLOVIR
SPL Moiety
TOPICAL\OINTMENT\ACYCLOVIR

product(s) by strength(s)

acyclovir 0.05 mg/mg topical ointment

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001870993ZoviraxNDAValeant Pharmaceuticals North America Llc1982-03-29ACYCLOVIRTOPICALOINTMENTNDA01860450278e0e-da1e-45ee-9fcb-672b2a219911

generic product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1003788700ANDAMylan Pharmaceuticals Inc.2013-04-03ACYCLOVIRTOPICALOINTMENTANDA202459ce3d5e8b-9401-40be-8ce7-4ea42113f4ab
2005911159NDA AUTHORIZED GENERICWatson Laboratories, Inc.2014-04-11ACYCLOVIRTOPICALOINTMENTNDA018604b360a808-a24d-4f3c-89a7-9941422d17d6
3422910106ANDAAvkare, Inc.2015-02-05ACYCLOVIRTOPICALOINTMENTANDA2046057758c9c7-b4c7-3c7c-e0d9-0a78e9c276ff
4510790550ANDAMylan Institutional Inc.2013-11-27ACYCLOVIRTOPICALOINTMENTANDA20245998109bfb-73ca-4f3c-81f7-393e4b666077
5651620835ANDAAmneal Pharmaceuticals2014-01-03ACYCLOVIRTOPICALOINTMENTANDA204605269e2203-347d-40dc-b794-11cf34690f27
6686820995NDA AUTHORIZED GENERICOceanside Pharmaceuticals2012-10-032016-06-30ACYCLOVIRTOPICALOINTMENTNDA018604944b7b73-5c1b-4ac7-832b-b9f15e067e80

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA202459ACYCLOVIRMYLAN PHARMACEUTICALS INC2013-04-03ANDA202459_001
2ANDA204605ACYCLOVIRAMNEAL PHARMACEUTICALS2014-06-18ANDA204605_001
3NDA018604ZOVIRAXVALEANT INTERNATIONAL BERMUDA1982-03-29NDA018604_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA202459_001RXACYCLOVIR (5%)TOPICALOINTMENTFalseAB2013-04-03ACYCLOVIR
2ANDA204605_001RXACYCLOVIR (5%)TOPICALOINTMENTFalseAB2014-06-18ACYCLOVIR
3NDA018604_001RXACYCLOVIR (5%)TOPICALOINTMENTTrueAB1982-03-29ZOVIRAX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1269e2203-347d-40dc-b794-11cf34690f27 (view SPL)Acyclovir Ointment, USP 5%prescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2014-09-057651620835
250278e0e-da1e-45ee-9fcb-672b2a219911 (view SPL)ZOVIRAX (acyclovir) Ointment 5%prescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE2014-11-202001870993
37758c9c7-b4c7-3c7c-e0d9-0a78e9c276ff (view SPL)Acyclovir Ointment, USP 5%prescriptionHuman PrescriptionAvkare, Inc.2015-02-051422910106
4944b7b73-5c1b-4ac7-832b-b9f15e067e80 (view SPL)Acyclovir Ointment 5%prescriptionHuman PrescriptionOceanside PharmaceuticalsMANUFACTURE2012-10-032686820995
598109bfb-73ca-4f3c-81f7-393e4b666077 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2015-06-172510790550
6b360a808-a24d-4f3c-89a7-9941422d17d6 (view SPL)Acyclovir Ointment 5 %prescriptionHuman PrescriptionWatson Laboratories, Inc.MANUFACTURE2015-04-173005911159
7ce3d5e8b-9401-40be-8ce7-4ea42113f4ab (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-02-285003788700

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII