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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200652
Company: HIKMA

Products on ANDA 200652

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	EQ 0.5MG BASE	TABLET;ORAL	Discontinued	None	No	No
ALOSETRON HYDROCHLORIDE	ALOSETRON HYDROCHLORIDE	EQ 1MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200652

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/2015	ORIG-1	Approval	Not Applicable		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200652Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200652Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/08/2023	SUPPL-9	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/200652s009ltr.pdf
05/05/2022	SUPPL-8	REMS - MODIFIED - D-N-A		Label is not available on this site.
10/18/2021	SUPPL-7	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/200652Orig1s007ltr.pdf
12/06/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
11/22/2016	SUPPL-4	REMS - MODIFIED - D-N-A	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200652Orig1s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/200652Orig1s004.pdf
03/24/2016	SUPPL-3	REMS-Modified		Label is not available on this site.
01/07/2016	SUPPL-2	REMS-Modified		Label is not available on this site.

Labels for ANDA 200652

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/04/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200652Orig1s000lbl.pdf

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