اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CUPRIMINE از شرکت VALEANT PHARMS INTL
New Drug Application (NDA): 019853
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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/04/1970 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/26/2004 | SUPPL-14 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19853s012,014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019853Orig1S014.pdf |
||
| 05/27/2003 | SUPPL-13 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19853slr013_cuprimine_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19853slr013ltr.pdf |
||
| 10/26/2004 | SUPPL-12 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19853s012,014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019853Orig1s012.pdf |
||
| 11/20/2003 | SUPPL-11 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19853slr007,011ltr.pdf |
|
| 03/01/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1994 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/2003 | SUPPL-7 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19853slr007,011ltr.pdf |
|
| 10/04/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/05/1989 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/25/1987 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/21/1987 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
| 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 |
CUPRIMINE
CAPSULE;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CUPRIMINE | PENICILLAMINE | 250MG | CAPSULE;ORAL | Prescription | Yes | AB | 019853 | VALEANT PHARMS INTL |
| PENICILLAMINE | PENICILLAMINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 209921 | ANI PHARMS |
| PENICILLAMINE | PENICILLAMINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 213310 | APOTEX |
| PENICILLAMINE | PENICILLAMINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 211867 | DR REDDYS |
| PENICILLAMINE | PENICILLAMINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 211735 | GRANULES |
| PENICILLAMINE | PENICILLAMINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 211231 | PAR PHARM INC |
| PENICILLAMINE | PENICILLAMINE | 250MG | CAPSULE;ORAL | Prescription | No | AB | 210976 | WATSON LABS INC |
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