Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040500
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY;RECTAL | Prescription | AB | No | No |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY;RECTAL | 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 |
---|---|---|---|---|---|---|---|
06/30/2003 | 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-3 | Labeling |
Label is not available on this site. |
PROMETHAZINE HYDROCHLORIDE
SUPPOSITORY;RECTAL; 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 | SUPPOSITORY;RECTAL | Prescription | No | AB | 216446 | ANNORA PHARMA |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 040428 | COSETTE |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 040500 | PADAGIS ISRAEL |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 12.5MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 040603 | TARO |
SUPPOSITORY;RECTAL; 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 | SUPPOSITORY;RECTAL | Prescription | No | AB | 216446 | ANNORA PHARMA |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 040428 | COSETTE |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 040500 | PADAGIS ISRAEL |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 25MG | SUPPOSITORY;RECTAL | Prescription | No | AB | 040603 | TARO |