6-Aminocaproic Acid Injectable Solution
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- American Regent, Inc. (2014-02-24)
- Oldest Current Product
- 1990-09-30
- License(s)
- ANDA
- RxNORM
- INJECTABLE SOLUTION\6-AMINOCAPROIC ACID
- FDAOB
- INJECTION\INJECTION\AMINOCAPROIC ACID\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\AMINOCAPROIC ACID
- SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\AMINOCAPROIC ACID
product(s) by strength(s)
6-aminocaproic acid 250 mg/ml injectable solution
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 005179120 | ANDA | American Regent, Inc. | 1990-09-30 | AMINOCAPROIC ACID | INTRAVENOUS | INJECTION, SOLUTION | ANDA071192 | f4f65667-c349-420b-b7b7-f20f3a4e4d4e |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|
| 1 | ANDA070010 | AMINOCAPROIC ACID IN PLASTIC CONTAINER | HOSPIRA INC | 1987-03-09 | ANDA070010_001 | 6-Aminocaproic Acid Injection | |
| 2 | ANDA070522 | AMINOCAPROIC ACID | True | ABRAXIS PHARMACEUTICAL PRODUCTS | 1986-06-17 | ANDA070522_001 | 6-Aminocaproic Acid Injection |
| 3 | ANDA070888 | AMINOCAPROIC ACID | True | HOSPIRA INC | 1988-06-16 | ANDA070888_001 | 6-Aminocaproic Acid Injection |
| 4 | ANDA071192 | AMINOCAPROIC ACID | LUITPOLD PHARMACEUTICALS INC | 1987-12-01 | ANDA071192_001 | 6-Aminocaproic Acid Injection | |
| 5 | NDA015229 | AMICAR | True | CLOVER PHARMACEUTICALS CORP | NDA015229_002 | 6-Aminocaproic Acid Injection | |
| 6 | NDA018590 | AMINOCAPROIC ACID | True | BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE | 1982-10-29 | NDA018590_001 | 6-Aminocaproic Acid Injection |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA070010_001 | RX | AMINOCAPROIC ACID (250MG/ML) | INJECTION | True | AP | 1987-03-09 | AMINOCAPROIC ACID IN PLASTIC CONTAINER |
| 2 | ANDA070522_001 | discontinued | AMINOCAPROIC ACID (250MG/ML) | INJECTION | False | 1986-06-17 | AMINOCAPROIC ACID | |
| 3 | ANDA070888_001 | discontinued | AMINOCAPROIC ACID (250MG/ML) | INJECTION | False | 1988-06-16 | AMINOCAPROIC ACID | |
| 4 | ANDA071192_001 | RX | AMINOCAPROIC ACID (250MG/ML) | INJECTION | False | AP | 1987-12-01 | AMINOCAPROIC ACID |
| 5 | NDA015229_002 | discontinued | AMINOCAPROIC ACID (250MG/ML) | INJECTION | False | AMICAR | ||
| 6 | NDA018590_001 | discontinued | AMINOCAPROIC ACID (250MG/ML) | INJECTION | False | 1982-10-29 | AMINOCAPROIC ACID |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | f4f65667-c349-420b-b7b7-f20f3a4e4d4e (view SPL) | AMINOCAPROIC ACID INJECTION, USP | prescription | Human Prescription | American Regent, Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE | 2014-02-24 | 6 | 005179120 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII