Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078801
Company: SYNTHON PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;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
04/27/2010 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
10/17/2011 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

TAMSULOSIN HYDROCHLORIDE

CAPSULE;ORAL; 0.4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLOMAX TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription Yes AB 020579 SANOFI AVENTIS US
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 207405 ALKEM LABS LTD
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 211885 ANBISON LAB
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 202010 ANCHEN PHARMS
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 202433 AUROBINDO PHARMA LTD
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 090377 IMPAX LABS
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 204645 MACLEODS PHARMS LTD
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 090408 MYLAN
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 078015 SANDOZ
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 090931 SUN PHARM INDS LTD
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 078801 SYNTHON PHARMS
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 077630 TEVA PHARMS
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 078938 WOCKHARDT
TAMSULOSIN HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE 0.4MG CAPSULE;ORAL Prescription No AB 078225 ZYDUS PHARMS USA INC

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