ALINIA از شرکت ROMARK

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New Drug Application (NDA): 021497

Company: ROMARK

Products on NDA 021497

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALINIA	NITAZOXANIDE	500MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021497

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/21/2004	ORIG-1	Approval	Type 3 – New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21497,21498s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21497,21498s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-497_21-498s001_Alinia.cfm

Action Date

Submission

Action Type

Submission Classification

Review Priority; Orphan Status

Letters, Reviews, Labels, Patient Package Insert

Notes

Url

07/21/2004

ORIG-1

Approval

Type 3 – New Dosage Form

PRIORITY; Orphan

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21497,21498s001lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21497,21498s001ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-497_21-498s001_Alinia.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/03/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
12/05/2012	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/11/2016	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021497s001,021498s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021497Orig1s001,021498Orig1s004ltr.pdf

Action Date

Submission

Supplement Categories or Approval Type

Letters, Reviews, Labels, Patient Package Insert

Note

Url

03/03/2015

SUPPL-4

Manufacturing (CMC)

Label is not available on this site.

12/05/2012

SUPPL-3

Manufacturing (CMC)

Label is not available on this site.

07/11/2016

SUPPL-1

Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021497s001,021498s004lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021497Orig1s001,021498Orig1s004ltr.pdf

Labels for NDA 021497

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021497s001,021498s004lbl.pdf
07/21/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21497,21498s001lbl.pdf

Therapeutic Equivalents for NDA 021497

ALINIA

TABLET;ORAL; 500MG

TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALINIA	NITAZOXANIDE	500MG	TABLET;ORAL	Prescription	Yes	AB	021497	ROMARK
NITAZOXANIDE	NITAZOXANIDE	500MG	TABLET;ORAL	Prescription	No	AB	213820	RISING

حتما بخوانید : CHLORDIAZEPOXIDE HYDROCHLORIDE از شرکت UPSHER SMITH LABS

منبع : www.accessdata.fda.gov

ALINIA از شرکت ROMARK