Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207567
Company: WATSON LABS TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE 250MG 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
02/07/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207567Orig1s000ltr.pdf

TRIENTINE HYDROCHLORIDE

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SYPRINE TRIENTINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription Yes AB 019194 BAUSCH
TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 210619 AMNEAL PHARMS LLC
TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 211076 DR REDDYS LABS LTD
TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 209415 KADMON PHARMS LLC
TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 209731 KADMON PHARMS LLC
TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 211134 MSN LABS PVT LTD
TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 211251 NAVINTA LLC
TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 210096 PAR PHARM INC
TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 207567 WATSON LABS TEVA
TRIENTINE HYDROCHLORIDE TRIENTINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 211554 ZYDUS PHARMS

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