Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203375
Company: ACELLA
Company: ACELLA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/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 |
---|---|---|---|---|---|---|---|
09/20/2016 | 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 |
---|---|---|---|---|---|
10/27/2022 | SUPPL-5 | Labeling-Proprietary Name Change |
Label is not available on this site. |
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
SYRUP;ORAL; 2MG/5ML;10MG/5ML;30MG/5ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BROMFED-DM | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | Yes | AA | 088811 | WOCKHARDT BIO AG |
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 203375 | ACELLA |
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 210647 | ALKEM LABS LTD |
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 213125 | CHARTWELL MOLECULAR |
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 207676 | DR REDDYS LABS SA |
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 205292 | PADAGIS US |
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 202940 | PHARM ASSOC |
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 205112 | TARO |
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP;ORAL | Prescription | No | AA | 211170 | WES PHARMA INC |