Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085362
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NOVOCAIN | PROCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| NOVOCAIN | PROCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 11/15/1979 | 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 |
|---|---|---|---|---|---|
| 02/14/2001 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 08/07/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/11/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/11/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/12/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/12/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |