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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212444
Company: MACLEODS PHARMS LTD

Products on ANDA 212444

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACYCLOVIR	ACYCLOVIR	5%	OINTMENT;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212444

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/19/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/05/2021	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 212444

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	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	211794	CIPLA
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	NORVIUM BIOSCIENCE
ACYCLOVIR	ACYCLOVIR	5%	OINTMENT;TOPICAL	Prescription	No	AB	205469	TARO
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

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