Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040712
Company: KVK TECH
Company: KVK TECH
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 |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | AB | No | No |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 50MG | 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 |
---|---|---|---|---|---|---|---|
07/31/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/040712s000LTR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/04/2007 | SUPPL-6 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
05/04/2007 | SUPPL-5 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
05/04/2007 | SUPPL-4 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
05/04/2007 | SUPPL-3 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
05/04/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
05/04/2007 | SUPPL-1 | Manufacturing (CMC)-New Strength |
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 | 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 |
TABLET;ORAL; 12.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 091179 | AMNEAL PHARMS NY |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 040712 | KVK TECH |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 040622 | PRINSTON INC |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 040673 | QUAGEN |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 209177 | STRIDES PHARMA |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | TABLET;ORAL | Prescription | No | AB | 040596 | ZYDUS PHARMS USA |
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 |