Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071388
Company: ROXANE
Company: ROXANE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE INTENSOL | PROPRANOLOL HYDROCHLORIDE | 80MG/ML | CONCENTRATE;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 |
|---|---|---|---|---|---|---|---|
| 05/15/1987 | 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 |
|---|---|---|---|---|---|
| 08/01/2001 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 02/20/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/20/2001 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/28/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/05/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 05/16/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 10/09/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 03/09/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 01/16/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 02/28/1990 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/21/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |