Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019853
Company: VALEANT PHARMS INTL
Company: VALEANT PHARMS INTL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CUPRIMINE | PENICILLAMINE | 250MG | CAPSULE;ORAL | Prescription | AB | Yes | Yes |
| CUPRIMINE | PENICILLAMINE | 125MG | CAPSULE;ORAL | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/26/2004 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf | |
| 10/26/2004 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf | |
| 05/27/2003 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19853slr013_cuprimine_lbl.pdf |
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