Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012947
Company: LEDERLE
Company: LEDERLE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|
| 04/18/1962 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/15/1993 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/26/1987 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 07/24/1987 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/26/1984 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/22/1982 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/08/1977 | SUPPL-11 | Efficacy |
Label is not available on this site. |