Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018555
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| YUTOPAR | RITODRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 12/12/1980 | 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 |
|---|---|---|---|---|---|
| 03/27/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 06/23/1987 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 11/19/1986 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 04/17/1986 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/27/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |