Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075090
Company: INDOCO

Products on ANDA 075090

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075090

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/1999	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75090ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/075090_ORIGINAL APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/08/2016	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
02/06/2006	SUPPL-7	Labeling		Label is not available on this site.
02/06/2006	SUPPL-6	Labeling		Label is not available on this site.
02/04/2003	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075090

ACYCLOVIR

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	No	AB	075677	APOTEX
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	No	AB	204313	CADILA
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	No	AB	201445	CADILA PHARMS LTD
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	No	AB	206261	CARLSBAD TECHNOLOGY
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	No	AB	074889	HERITAGE PHARMS
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	No	AB	075090	INDOCO
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	No	AB	074578	TEVA
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	No	AB	212173	YILING