Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212492
Company: AMNEAL
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 500MG | 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 |
---|---|---|---|---|---|---|---|
11/26/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212492Orig1s000ltr.pdf |
AMINOCAPROIC ACID
TABLET;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 500MG | TABLET;ORAL | Prescription | No | AB | 212492 | AMNEAL |
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 500MG | TABLET;ORAL | Prescription | No | AB | 211629 | ANI PHARMS |
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 500MG | TABLET;ORAL | Prescription | No | AB | 213928 | CARNEGIE |
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 500MG | TABLET;ORAL | Prescription | No | AB | 212938 | MSN |
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 500MG | TABLET;ORAL | Prescription | No | AB | 213944 | OPTIMUS |
AMINOCAPROIC ACID | AMINOCAPROIC ACID | 500MG | TABLET;ORAL | Prescription | No | AB | 209060 | SUNNY |