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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064171
Company: SUN PHARM INDS INC

Products on ANDA 064171

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PAROMOMYCIN SULFATE	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064171

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/1997	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/05/2001	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 064171

PAROMOMYCIN SULFATE

CAPSULE;ORAL; EQ 250MG BASE
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PAROMOMYCIN SULFATE	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AA	065173	HERITAGE PHARMS
PAROMOMYCIN SULFATE	PAROMOMYCIN SULFATE	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AA	064171	SUN PHARM INDS INC

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