Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018104
Company: PHARMACIA AND UPJOHN
Company: PHARMACIA AND UPJOHN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYLOREL | GUANADREL SULFATE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| HYLOREL | GUANADREL SULFATE | 25MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/29/1982 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 08/01/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 08/01/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 10/07/1986 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 08/20/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 08/20/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 09/13/1983 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/01/1983 | SUPPL-1 | Labeling |
Label is not available on this site. |