Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020577
Company: LUKARE MEDICAL LLC
Company: LUKARE MEDICAL LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ELLIOTTS B SOLUTION | CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML | INJECTABLE;INTRATHECAL | Prescription | None | 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 |
|---|---|---|---|---|---|---|---|
| 09/27/1996 | 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 |
|---|---|---|---|---|---|
| 11/29/2016 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/17/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/18/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/14/2012 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/11/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/17/2000 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 05/22/1998 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 05/22/1998 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 12/02/1997 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |