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
ADALAT CC از شرکت ALVOGEN
New Drug Application (NDA): 020198
Company: ALVOGEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADALAT CC | NIFEDIPINE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued |
None |
Yes | No |
| ADALAT CC | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued |
None |
Yes | No |
| ADALAT CC | NIFEDIPINE | 90MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 04/21/1993 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
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 |
|---|---|---|---|---|---|
| 05/17/2016 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/2015 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/2011 | SUPPL-23 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020198s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020198s023ltr.pdf |
||
| 03/03/2010 | SUPPL-22 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020198s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020198s022ltr.pdf |
||
| 04/01/2005 | SUPPL-17 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20198s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20198s017ltr.pdf |
||
| 04/13/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/18/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1996 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/14/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1996 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/28/1994 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/07/1994 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 12/06/1993 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/23/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/28/2011 | SUPPL-23 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020198s023lbl.pdf | |
| 03/03/2010 | SUPPL-22 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020198s022lbl.pdf | |
| 04/01/2005 | SUPPL-17 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20198s017lbl.pdf |
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