Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213825
Company: BELCHER
Company: BELCHER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;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 |
---|---|---|---|---|---|---|---|
04/08/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
AMINOCAPROIC ACID
SOLUTION;ORAL; 0.25GM/ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Prescription | No | AA | 212780 | AMNEAL |
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Prescription | No | AA | 216464 | ANNORA PHARMA |
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Prescription | No | AA | 216804 | AUROBINDO PHARMA |
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Prescription | No | AA | 213825 | BELCHER |
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Prescription | No | AA | 214140 | CARNEGIE |
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Prescription | No | AA | 215510 | FLORIDA |
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Prescription | No | AA | 213213 | SUNNY |
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Prescription | No | AA | 214458 | TARO |
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Prescription | No | AA | 212494 | TULEX PHARMS INC |