Levocarnitine Oral Solution
- Brand(s)
- Carnitor
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Sigma-Tau Pharmaceuticals, Inc. (2015-06-18)
- Oldest Current Product
- 1986-04-10
- License(s)
- NDA, ANDA
- RxNORM
- ORAL SOLUTION\LEVOCARNITINE
- FDAOB
- ORAL\SOLUTION\LEVOCARNITINE
ORAL\TABLET\LEVOCARNITINE - SPL Active
- ORAL\SOLUTION\LEVOCARNITINE
- SPL Moiety
- ORAL\SOLUTION\LEVOCARNITINE
product(s) by strength(s)
levocarnitine 100 mg/ml oral solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 544820148 | Carnitor | NDA | Sigma-Tau Pharmaceuticals, Inc. | 1986-04-10 | LEVOCARNITINE | ORAL | SOLUTION | NDA019257 | dd904490-83f3-4cd3-bb6f-68e28509b4b6 |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 503830171 | ANDA | Hi-Tech Pharmacal Co., Inc. | 2007-10-25 | LEVOCARNITINE | ORAL | SOLUTION | ANDA077399 | 3563c2f5-9814-4d55-8d90-bd7d6dcff36b |
| 2 | 649800503 | ANDA | Rising Pharmaceuticals, Inc. | 2004-09-20 | LEVOCARNITINE | ORAL | SOLUTION | ANDA076851 | ada35959-e317-4161-ae79-3475096c679f |
relabeler product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | equivalent product | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 521250743 | ANDA | Remedyrepack Inc. | 2013-10-08, 2013-11-29 | LEVOCARNITINE | ORAL | SOLUTION | 649800503 | ANDA076851 | 1dd9f5b4-ed67-4fed-aee2-6775d760b30a, 4ffa9844-7c03-456b-9aa2-53090bedb467 |
application(s)
| # | id | title | applicant | approved | approved drug | in other drug docs |
|---|---|---|---|---|---|---|
| 1 | ANDA076851 | LEVOCARNITINE | LYNE LABORATORIES INC | 2004-08-10 | ANDA076851_001 | Levocarnitine Oral Tablet |
| 2 | ANDA077399 | LEVOCARNITINE | HI TECH PHARMACAL CO INC | 2007-10-25 | ANDA077399_001 | Levocarnitine Oral Tablet |
| 3 | NDA018948 | CARNITOR | SIGMA TAU PHARMACEUTICALS INC | 1985-12-27 | NDA018948_001, NDA018948_002 | Levocarnitine Oral Tablet |
| 4 | NDA019257 | CARNITOR | SIGMA TAU PHARMACEUTICALS INC | 1986-04-10 | NDA019257_001, NDA019257_002 | Levocarnitine Oral Tablet |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA076851_001 | RX | LEVOCARNITINE (1GM/10ML) | ORAL | SOLUTION | False | AA | 2004-08-10 | LEVOCARNITINE |
| 2 | ANDA077399_001 | RX | LEVOCARNITINE (1GM/10ML) | ORAL | SOLUTION | False | AA | 2007-10-25 | LEVOCARNITINE |
| 3 | NDA018948_001 | RX | LEVOCARNITINE (330MG) | ORAL | TABLET | True | AB | 1985-12-27 | CARNITOR |
| 4 | NDA018948_002 | discontinued | LEVOCARNITINE (1GM/10ML) | ORAL | SOLUTION | False | 1988-04-27 | CARNITOR | |
| 5 | NDA019257_001 | RX | LEVOCARNITINE (1GM/10ML) | ORAL | SOLUTION | True | AA | 1986-04-10 | CARNITOR |
| 6 | NDA019257_002 | RX | LEVOCARNITINE (1GM/10ML) | ORAL | SOLUTION | False | AA | 2007-03-28 | CARNITOR |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 1dd9f5b4-ed67-4fed-aee2-6775d760b30a (view SPL) | Levocarnitine Oral Solution USP1g/10mL(118mL multidose) | prescription | Human Prescription | Remedyrepack Inc. | 2013-11-29 | 1 | 521250743 | |
| 2 | 3563c2f5-9814-4d55-8d90-bd7d6dcff36b (view SPL) | Levocarnitine Oral Solution USP(1 g per 10 mL multidose) | prescription | Human Prescription | Hi-Tech Pharmacal Co., Inc. | MANUFACTURE | 2010-08-10 | 1 | 503830171 |
| 3 | 4ffa9844-7c03-456b-9aa2-53090bedb467 (view SPL) | Levocarnitine Oral Solution USP1g/10mL(118mL multidose) | prescription | Human Prescription | Remedyrepack Inc. | 2013-10-08 | 1 | 521250743 | |
| 4 | ada35959-e317-4161-ae79-3475096c679f (view SPL) | Levocarnitine Oral Solution USP 1g/10mL (118mL multidose) | prescription | Human Prescription | Rising Pharmaceuticals, Inc. | manufacture | 2014-12-30 | 4 | 649800503 |
| 5 | b2cbc620-59fd-47b6-9e4b-7e3e31533a1c (view SPL) | Carnitor (levocarnitine) Oral Solution (1 g per 10 mL mulitdose) | prescription | Human Prescription | Sigma-Tau Pharmaceuticals, Inc. | API MANUFACTURE, MANUFACTURE | 2015-06-18 | 6 | 544820145 |
| 6 | dd904490-83f3-4cd3-bb6f-68e28509b4b6 (view SPL) | Carnitor SF (levocarnitine) Sugar-Free Oral Solution (1 g per 10 mL mulitdose) | prescription | Human Prescription | Sigma-Tau Pharmaceuticals, Inc. | API MANUFACTURE, MANUFACTURE | 2015-06-18 | 6 | 544820148 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII