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): 019257
Company: LEADIANT BIOSCI INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARNITOR | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Prescription |
AA |
Yes | Yes |
| CARNITOR SF | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Prescription |
AA |
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 |
|---|---|---|---|---|---|---|---|
| 04/10/1986 | 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-14 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018948s028,019257s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018948Orig1s028,019257Orig1s014ltr.pdf |
||
| 05/29/2015 | SUPPL-12 | 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 |
||
| 03/28/2007 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018948s024,019257s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018948s024,019257ltr.pdf |
||
| 04/15/2002 | SUPPL-10 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18948s22ltr.pdf |
||
| 12/15/1998 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/27/1997 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/17/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1995 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/25/1990 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1988 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/12/1989 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1986 | 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 |
|---|---|---|---|---|---|
| 04/17/2018 | SUPPL-14 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018948s028,019257s014lbl.pdf | |
| 05/29/2015 | SUPPL-12 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf | |
| 03/28/2007 | SUPPL-11 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018948s024,019257s011lbl.pdf | |
| 03/28/2007 | SUPPL-11 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018948s024,019257s011lbl.pdf | |
| 04/15/2002 | SUPPL-10 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf |
CARNITOR
SOLUTION;ORAL; 1GM/10ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARNITOR | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Prescription | Yes | AA | 019257 | LEADIANT BIOSCI INC |
| CARNITOR SF | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Prescription | Yes | AA | 019257 | LEADIANT BIOSCI INC |
| LEVOCARNITINE | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Prescription | No | AA | 077399 | AKORN |
| LEVOCARNITINE | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Prescription | No | AA | 076851 | LYNE |
| LEVOCARNITINE | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Prescription | No | AA | 211676 | NOVITIUM PHARMA |
| LEVOCARNITINE SF | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Prescription | No | AA | 211676 | NOVITIUM PHARMA |
CARNITOR SF
SOLUTION;ORAL; 1GM/10ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARNITOR | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Prescription | Yes | AA | 019257 | LEADIANT BIOSCI INC |
| CARNITOR SF | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Prescription | Yes | AA | 019257 | LEADIANT BIOSCI INC |
| LEVOCARNITINE | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Prescription | No | AA | 077399 | AKORN |
| LEVOCARNITINE | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Prescription | No | AA | 076851 | LYNE |
| LEVOCARNITINE | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Prescription | No | AA | 211676 | NOVITIUM PHARMA |
| LEVOCARNITINE SF | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Prescription | No | AA | 211676 | NOVITIUM PHARMA |
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