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 | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/26/1978 | 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 |
|---|---|---|---|---|---|
| 05/07/2002 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 01/29/2001 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 03/12/1999 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1999 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1995 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 04/24/1995 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 06/01/1995 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1995 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1995 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/1993 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1993 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 11/14/1991 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 07/24/1989 | SUPPL-29 | Bioequivalence |
Label is not available on this site. |
||
| 08/17/1989 | SUPPL-28 | Bioequivalence |
Label is not available on this site. |
||
| 07/11/1989 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1989 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1988 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/02/1986 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1984 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1984 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1983 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1983 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
AMITRIPTYLINE HYDROCHLORIDE
TABLET; ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE | 100MG | TABLET; ORAL | Prescription | No | AB | 086158 | MYLAN |