Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017871
Company: BAUSCH
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEMSER | METYROSINE | 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 |
|---|---|---|---|---|---|---|---|
| 10/03/1979 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/15/2014 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/2003 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17871slr011ltr.pdf |
| 12/12/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/1988 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1985 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/06/1985 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/25/1984 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/14/1980 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
DEMSER
CAPSULE;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEMSER | METYROSINE | 250MG | CAPSULE;ORAL | Prescription | Yes | AB | 017871 | BAUSCH |
| METYROSINE | METYROSINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 213734 | AMNEAL |
| METYROSINE | METYROSINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 218620 | DR REDDYS LABS SA |
| METYROSINE | METYROSINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 215541 | LEADING |