Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018144
Company: PARKE DAVIS
Company: PARKE DAVIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CENTRAX | PRAZEPAM | 5MG | CAPSULE;ORAL | Discontinued | None | No | No |
| CENTRAX | PRAZEPAM | 10MG | CAPSULE;ORAL | Discontinued | None | No | No |
| CENTRAX | PRAZEPAM | 20MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 11/30/1979 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 04/26/1996 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 04/26/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 04/26/1996 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 04/26/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 04/26/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 05/01/1984 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 05/27/1980 | SUPPL-1 | Labeling |
Label is not available on this site. |