Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019194
Company: BAUSCH
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 |
|---|---|---|---|---|---|---|---|---|
| SYPRINE | TRIENTINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Prescription | Yes | AB | 019194 | BAUSCH |
| TRIENTINE HYDROCHLORIDE | TRIENTINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 211076 | DR REDDYS |
| TRIENTINE HYDROCHLORIDE | TRIENTINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 209945 | ECI PHARMS LLC |
| TRIENTINE HYDROCHLORIDE | TRIENTINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 216356 | HETERO LABS LTD III |
| TRIENTINE HYDROCHLORIDE | TRIENTINE HYDROCHLORIDE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 211134 | MSN |
| 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 | 212238 | RISING |
| 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 |