Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019445
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEXTROSE 25% | DEXTROSE | 250MG/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
DEXTROSE 50% | DEXTROSE | 500MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
06/03/1986 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/23/1998 | SUPPL-6 | Efficacy-New Indication |
Label is not available on this site. |
||
11/23/1998 | SUPPL-4 | Efficacy-New Patient Population |
Label is not available on this site. |
DEXTROSE 25%
There are no Therapeutic Equivalents.
DEXTROSE 50%
INJECTABLE;INJECTION; 500MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEXTROSE 50% | DEXTROSE | 500MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019445 | HOSPIRA |
DEXTROSE 50% | DEXTROSE | 500MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203451 | INTL MEDICATION SYS |