Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019194
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYPRINE TRIENTINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/08/1985 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019194Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/03/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/10/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

01/17/2001 SUPPL-6 Labeling

Label is not available on this site.

02/08/2000 SUPPL-5 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19194-S005_Syprine.pdf
02/24/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/24/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/16/1988 SUPPL-2 Labeling

Label is not available on this site.

10/15/1986 SUPPL-1 Labeling

Label is not available on this site.

SYPRINE

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOVIQUE TRIENTINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 209731 KADMON PHARMS LLC
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 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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