Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200652
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription AB No No
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription AB No No
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
11/22/2016 SUPPL-4 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200652Orig1s004ltr.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.

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

ALOSETRON HYDROCHLORIDE

TABLET;ORAL; EQ 0.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 206647 AMNEAL PHARMS
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 200652 WEST-WARD PHARMS INT
LOTRONEX ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET;ORAL Prescription Yes AB 021107 SEBELA IRELAND LTD

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 206647 AMNEAL PHARMS
ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 200652 WEST-WARD PHARMS INT
LOTRONEX ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription Yes AB 021107 SEBELA IRELAND LTD

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