Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080429
Company: BIONPHARMA
Company: BIONPHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANESTACON | LIDOCAINE HYDROCHLORIDE | 2% | JELLY;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/11/1974 | 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 |
|---|---|---|---|---|---|
| 01/16/1996 | SUPPL-18 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/12/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/12/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 06/05/1991 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/16/1984 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/13/1983 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/08/1983 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |