Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205591
Company: G AND W LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/13/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

ACYCLOVIR

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 204605 AMNEAL PHARMS
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 206633 FOUGERA PHARMS INC
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 205591 G AND W LABS INC
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 205510 GLENMARK PHARMS LTD
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 202459 MYLAN PHARMS INC
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 205469 TARO
ACYCLOVIR ACYCLOVIR 5% OINTMENT;TOPICAL Prescription No AB 206437 TOLMAR
ZOVIRAX ACYCLOVIR 5% OINTMENT;TOPICAL Prescription Yes AB 018604 VALEANT BERMUDA

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