Drugs@FDA: FDA-Approved Drugs
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET; ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 04/10/1978 | 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 |
|---|---|---|---|---|---|
| 07/02/1993 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 05/07/2002 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 01/29/2001 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 03/12/1999 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1999 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1995 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 04/24/1995 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 06/01/1995 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1995 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1995 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/1993 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1991 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 08/17/1989 | SUPPL-40 | Bioequivalence |
Label is not available on this site. |
||
| 08/17/1989 | SUPPL-39 | Bioequivalence |
Label is not available on this site. |
||
| 07/11/1989 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1989 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1988 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1986 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/23/1984 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1984 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1983 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1983 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
AMITRIPTYLINE HYDROCHLORIDE
TABLET; ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 25MG | TABLET; ORAL | Prescription | No | AB | 086010 | MYLAN |