Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087266
Company: OLTA PHARMS
Company: OLTA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LINDANE | LINDANE | 1% | SHAMPOO;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 |
|---|---|---|---|---|---|---|---|
| 12/17/1981 | 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 |
|---|---|---|---|---|---|
| 04/05/2004 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/09/2001 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/29/2000 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/29/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/17/1996 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 08/02/1994 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/15/1991 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1990 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/03/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |