Drugs@FDA: FDA-Approved Drugs
Company: LEDERLE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ARTANE | TRIHEXYPHENIDYL HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ARTANE | TRIHEXYPHENIDYL HYDROCHLORIDE | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| ARTANE | TRIHEXYPHENIDYL HYDROCHLORIDE | 2MG/5ML | ELIXIR;ORAL | Discontinued | None | No | No |
| ARTANE | TRIHEXYPHENIDYL HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 05/13/1949 | 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 |
|---|---|---|---|---|---|
| 06/25/2003 | SUPPL-36 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06773slr036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/006773_S036_ARTANE.pdf |
| 01/28/1998 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1997 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/02/1997 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1997 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/19/1997 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/19/1997 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/19/1997 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/17/1996 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/27/1996 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/25/1993 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/26/1987 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 07/24/1987 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 06/26/1984 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/10/1976 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/11/1976 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/11/1976 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/28/1976 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/10/1975 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/11/1975 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/29/1975 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 01/27/1976 | SUPPL-9 | Unspecified |
Label is not available on this site. |