Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Discontinued | None | No | No |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 02/18/1975 | 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 |
|---|---|---|---|---|---|
| 05/22/2009 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 06/09/2005 | SUPPL-59 | Labeling |
Label is not available on this site. |
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| 12/22/2004 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 12/16/2002 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/19/2002 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/2002 | SUPPL-52 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/23/2001 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/15/1998 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/03/1996 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1995 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1995 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/28/1991 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 11/01/1988 | SUPPL-44 | Labeling |
Label is not available on this site. |
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| 01/03/1986 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/07/1985 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/13/1983 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1983 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1983 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1983 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1982 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1982 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1981 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1982 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1982 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1982 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1982 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1982 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
PROMETHAZINE HYDROCHLORIDE
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 091179 | AMNEAL PHARMS NY |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040712 | KVK TECH |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040713 | KVK TECH |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040622 | PRINSTON INC |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040673 | QUAGEN |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 084176 | SANDOZ |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 209177 | STRIDES PHARMA |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 083711 | WATSON LABS |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040596 | ZYDUS PHARMS USA |
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 | 209177 | STRIDES PHARMA |
| 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 |