Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071438
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RITODRINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER | RITODRINE HYDROCHLORIDE | 30MG/100ML | INJECTABLE;INJECTION | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 01/22/1991 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/09/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/10/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/02/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1996 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 10/08/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |