Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083426
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE 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 |
|---|---|---|---|---|---|---|---|
| 09/19/1973 | 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 |
|---|---|---|---|---|---|
| 06/09/2005 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 12/22/2004 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 04/25/2001 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1998 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1991 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1991 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1989 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 03/29/1989 | SUPPL-33 | Bioequivalence |
Label is not available on this site. |
||
| 12/13/1983 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1997 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
PROMETHAZINE HYDROCHLORIDE
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 091179 | AMNEAL PHARMS NY |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040712 | KVK TECH |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040622 | PRINSTON INC |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040673 | QUAGEN |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 084176 | SANDOZ |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 083426 | WATSON LABS |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040596 | ZYDUS PHARMS USA |