Acyclovir Oral Suspension

Brand(s)
Zovirax
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Renaissance Pharma, Inc. (2014-09-04)
Oldest Current Product
2002-09-03
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL SUSPENSION\ACYCLOVIR
FDAOB
ORAL\SUSPENSION\ACYCLOVIR
SPL Active
ORAL\SUSPENSION\ACYCLOVIR
SPL Moiety
ORAL\SUSPENSION\ACYCLOVIR

product(s) by strength(s)

acyclovir 40 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1400760953ZoviraxNDAPrestium Pharma, Inc.2014-02-07ACYCLOVIRORALSUSPENSIONNDA0199096fe0ab86-9d81-461e-9c84-6ba724a91318

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004720082ANDAActavis Pharma, Inc.2002-09-03ACYCLOVIRORALSUSPENSIONANDA074738a4c1305c-f18c-4fb0-83d8-2822341f2dfa
2400850842NDA AUTHORIZED GENERICRenaissance Pharma, Inc.2014-09-03ACYCLOVIRORALSUSPENSIONNDA019909c99d1396-4d4d-4890-aa09-5dfcdc3e7ece
3503830810ANDAHi-Tech Pharmacal Co., Inc.2005-06-07ACYCLOVIRORALSUSPENSIONANDA07702662bdcf22-51f3-4c81-9bd4-a2dc48bec580

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1178560082ANDAAtlantic Biologicals Corps2005-06-07ACYCLOVIRORALSUSPENSION503830810ANDA077026300bb5fb-557c-4045-993f-fcc895b4bd3f
2548685687ANDAPhysicians Total Care, Inc.2006-10-03ACYCLOVIRORALSUSPENSION50383081016ANDA077026dcc29902-1fe6-4713-947e-335503959464
3687880715ANDAPreferred Pharmaceuticals, Inc.2011-03-18ACYCLOVIRORALSUSPENSION503830810ANDA0770260a1eb087-50a2-441a-a3fe-3d93e31fe39f
4687889783ANDAPreferred Pharmaceuticals, Inc.2012-07-27ACYCLOVIRORALSUSPENSION004720082ANDA074738bdee576a-24bf-41a0-b948-e4c8a33cc8d0

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA074738ACYCLOVIRACTAVIS MID ATLANTIC LLC1997-04-28ANDA074738_001
2ANDA077026ACYCLOVIRHI TECH PHARMACAL CO INC2005-06-07ANDA077026_001
3NDA019909ZOVIRAXDELCOR ASSET CORP1989-12-22NDA019909_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074738_001RXACYCLOVIR (200MG/5ML)ORALSUSPENSIONFalseAB1997-04-28ACYCLOVIR
2ANDA077026_001RXACYCLOVIR (200MG/5ML)ORALSUSPENSIONFalseAB2005-06-07ACYCLOVIR
3NDA019909_001RXACYCLOVIR (200MG/5ML)ORALSUSPENSIONTrueAB1989-12-22ZOVIRAX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10a1eb087-50a2-441a-a3fe-3d93e31fe39f (view SPL)Acyclovir Oral Suspension, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2013-12-245687880715
2300bb5fb-557c-4045-993f-fcc895b4bd3f (view SPL)Acyclovir Oral Suspension, USPprescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2010-06-163178560082
362bdcf22-51f3-4c81-9bd4-a2dc48bec580 (view SPL)Acyclovir Oral Suspension, USPprescriptionHuman PrescriptionHi-Tech Pharmacal Co., Inc.2010-06-162503830810
46fe0ab86-9d81-461e-9c84-6ba724a91318 (view SPL)ZOVIRAX (acyclovir) Capsules ZOVIRAX (acyclovir) Tablets ZOVIRAX (acyclovir) SuspensionprescriptionHuman PrescriptionPrestium Pharma, Inc.MANUFACTURE2014-02-101400760953, 400760945, 400760949, 400760991Acyclovir Oral Tablet
Acyclovir Oral Capsule
5a4c1305c-f18c-4fb0-83d8-2822341f2dfa (view SPL)ACYCLOVIR ORAL SUSPENSION USPprescriptionHuman PrescriptionActavis Pharma, Inc.2010-05-122004720082
6bdee576a-24bf-41a0-b948-e4c8a33cc8d0 (view SPL)ACYCLOVIR ORAL SUSPENSION USP FORM NO. 0082 VC3361 Rev. 05/09 Rx OnlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2012-07-271687889783
7c99d1396-4d4d-4890-aa09-5dfcdc3e7ece (view SPL)Acyclovir SuspensionprescriptionHuman PrescriptionRenaissance Pharma, Inc.MANUFACTURE2014-09-042400850842
8dcc29902-1fe6-4713-947e-335503959464 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-07-091548685687

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