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
CYLERT از شرکت ABBOTT
New Drug Application (NDA): 016832
Company: ABBOTT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYLERT | PEMOLINE | 18.75MG | TABLET;ORAL | Discontinued |
None |
No | No |
| CYLERT | PEMOLINE | 37.5MG | TABLET;ORAL | Discontinued |
None |
No | No |
| CYLERT | PEMOLINE | 75MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 01/27/1975 | 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 |
|---|---|---|---|---|---|
| 11/21/2003 | SUPPL-22 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/016832s022_017703s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16832slr022,17703slr018ltr.pdf |
||
| 01/06/2003 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/12/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/04/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/28/1999 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 05/08/1998 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/016832a_s016.pdf |
|
| 12/12/1997 | SUPPL-15 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/016832a_s015.pdf |
|
| 09/09/1996 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/1996-016832a_s014.pdf |
|
| 04/11/1996 | SUPPL-13 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/1996-016832a_s013.pdf |
|
| 02/16/1990 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1987 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/06/1984 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/30/1979 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/06/1978 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/12/1977 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/14/1979 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/25/1975 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/21/2003 | SUPPL-22 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/016832s022_017703s018lbl.pdf |
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