Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019002
Company: JOHNSON AND JOHNSON
Company: JOHNSON AND JOHNSON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VASCOR | BEPRIDIL HYDROCHLORIDE | 200MG | TABLET;ORAL | Discontinued | None | No | No |
| VASCOR | BEPRIDIL HYDROCHLORIDE | 300MG | TABLET;ORAL | Discontinued | None | No | No |
| VASCOR | BEPRIDIL HYDROCHLORIDE | 400MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/28/1990 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/06/2001 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 03/10/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 06/28/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/28/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/28/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 01/28/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 05/12/1994 | SUPPL-2 | Manufacturing (CMC)-Control |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019002-S2_VASCOR TABLETS_toc.cfm |
| 10/06/1993 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |