Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078213
Company: NORTHSTAR HLTHCARE
Company: NORTHSTAR HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 20MG | TABLET;ORAL | Discontinued | None | No | No |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 40MG | TABLET;ORAL | Discontinued | None | No | No |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 60MG | TABLET;ORAL | Discontinued | None | No | No |
| PROPRANOLOL HYDROCHLORIDE | PROPRANOLOL HYDROCHLORIDE | 80MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/10/2008 | 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 |
|---|---|---|---|---|---|
| 06/11/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/11/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/27/2012 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/01/2011 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 12/15/2008 | SUPPL-1 | Labeling |
Label is not available on this site. |