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
CARNITOR از شرکت LEADIANT BIOSCI INC
New Drug Application (NDA): 020182
Company: LEADIANT BIOSCI INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARNITOR | LEVOCARNITINE | 200MG/ML | INJECTABLE;INJECTION | Prescription |
AP |
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 |
|---|---|---|---|---|---|---|---|
| 12/16/1992 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
PRIORITY; Orphan |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/17/2018 | SUPPL-15 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020182s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/20182Orig1s015ltr.pdf |
||
| 05/29/2015 | SUPPL-13 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018948Orig1s026,019257Orig1s012,020182Orig1s013ltr.pdf |
||
| 04/15/2002 | SUPPL-8 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18948s22ltr.pdf |
||
| 05/16/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1999 | SUPPL-6 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20182s6_Carnitor_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20182S6LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20182S6_Carnitor.cfm |
||
| 12/15/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/01/1997 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/27/1997 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/10/1995 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/07/1995 | 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 |
|---|---|---|---|---|---|
| 04/17/2018 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020182s015lbl.pdf | |
| 05/29/2015 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf | |
| 04/15/2002 | SUPPL-8 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf | |
| 12/15/1999 | SUPPL-6 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20182s6_Carnitor_prntlbl.pdf |
CARNITOR
INJECTABLE;INJECTION; 200MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARNITOR | LEVOCARNITINE | 200MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020182 | LEADIANT BIOSCI INC |
| LEVOCARNITINE | LEVOCARNITINE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075861 | AM REGENT |
| LEVOCARNITINE | LEVOCARNITINE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075567 | HIKMA PHARMS |
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