Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203800
Company: MYLAN LABS LTD
Company: MYLAN LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
| LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
| LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 350MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 05/19/2017 | ORIG-1 | Approval |
Label is not available on this site. |
LEUCOVORIN CALCIUM PRESERVATIVE FREE
INJECTABLE;INJECTION; EQ 100MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 217021 | HAINAN POLY |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 089717 | HIKMA |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216590 | KINDOS |
| LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203800 | MYLAN LABS LTD |
| LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 100MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 200753 | SAGENT PHARMS |
INJECTABLE;INJECTION; EQ 200MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 217021 | HAINAN POLY |
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216590 | KINDOS |
| LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040258 | FRESENIUS KABI USA |
| LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040056 | HIKMA |
| LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203800 | MYLAN LABS LTD |
| LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 200MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 200753 | SAGENT PHARMS |
INJECTABLE;INJECTION; EQ 350MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 350MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 216590 | KINDOS |
| LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 350MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040335 | HIKMA |
| LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 350MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203800 | MYLAN LABS LTD |
| LEUCOVORIN CALCIUM PRESERVATIVE FREE | LEUCOVORIN CALCIUM | EQ 350MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 200855 | SAGENT PHARMS |