Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040891
Company: NOSTRUM LABS INC
Company: NOSTRUM LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | SYRUP;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
03/13/2009 | ORIG-1 | Approval |
Label is not available on this site. |
PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL; 6.25MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040026 | CHARTWELL RX |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040891 | NOSTRUM LABS INC |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | SYRUP;ORAL | Prescription | No | AA | 213890 | QUAGEN |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | SYRUP;ORAL | Prescription | No | AA | 040718 | TARO |
PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | SYRUP;ORAL | Prescription | No | AA | 091675 | TRIS PHARMA INC |
PROMETHAZINE PLAIN | PROMETHAZINE HYDROCHLORIDE | 6.25MG/5ML | SYRUP;ORAL | Prescription | Yes | AA | 087953 | WOCKHARDT BIO AG |