Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040177
Company: PHARM ASSOC
Company: PHARM ASSOC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRIHEXYPHENIDYL HYDROCHLORIDE | TRIHEXYPHENIDYL HYDROCHLORIDE | 2MG/5ML | ELIXIR;ORAL | Prescription | AA | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/17/1997 | 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 |
---|---|---|---|---|---|
06/30/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
10/04/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
TRIHEXYPHENIDYL HYDROCHLORIDE
ELIXIR;ORAL; 2MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TRIHEXYPHENIDYL HYDROCHLORIDE | TRIHEXYPHENIDYL HYDROCHLORIDE | 2MG/5ML | ELIXIR;ORAL | Prescription | No | AA | 040251 | MIKART |
TRIHEXYPHENIDYL HYDROCHLORIDE | TRIHEXYPHENIDYL HYDROCHLORIDE | 2MG/5ML | ELIXIR;ORAL | Prescription | No | AA | 040177 | PHARM ASSOC |