Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 077399
Company: HI TECH PHARMA
Company: HI TECH PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVOCARNITINE | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 10/25/2007 | ORIG-1 | Approval |
Label is not available on this site. |
LEVOCARNITINE
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 | HI TECH PHARMA |
| LEVOCARNITINE | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Prescription | No | AA | 076851 | LYNE |
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