Atracurium Injectable Solution
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Aurobindo Pharma Limited (2015-07-29)
- Oldest Current Product
- 2012-05-01
- License(s)
- ANDA
- RxNORM
- INJECTABLE SOLUTION\ATRACURIUM
- FDAOB
- INJECTION\INJECTION\ATRACURIUM BESYLATE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, SOLUTION\ATRACURIUM BESYLATE
- SPL Moiety
- INTRAVENOUS\INJECTION, SOLUTION\ATRACURIUM
product(s) by strength(s)
atracurium besylate 10 mg/ml injectable solution
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004091105 | ANDA | Hospira, Inc. | 2012-10-18 | ATRACURIUM BESYLATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA090761 | de1c2dcd-295b-47ce-b7a1-a8be59939a54 |
| 2 | 250210672 | ANDA | Sagent Pharmaceuticals | 2012-05-01, 2015-07-31 | ATRACURIUM BESYLATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA091489 | 5562756e-7475-2d4c-696e-757834416c6c, 98ed3c4c-5e53-46c1-8110-6ae41531e36b, f25cc5a7-0eb0-4902-b402-fe021d7051da |
| 3 | 551500217 | ANDA | Auromedics Pharma Llc | 2015-04-08 | ATRACURIUM BESYLATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA206011 | f7b6a720-05a7-4d6a-9200-21bdc90fc1c4 |
| 4 | 658620985 | ANDA | Aurobindo Pharma Limited | 2015-04-08 | ATRACURIUM BESYLATE | INTRAVENOUS | INJECTION, SOLUTION | ANDA206011 | c3e0a3b9-535d-456b-9a1f-fa18a4d4e38f |
application(s)
| # | id | title | deprecated | applicant | approved | approved drug | in other drug docs |
|---|---|---|---|---|---|---|---|
| 1 | ANDA074632 | ATRACURIUM BESYLATE | True | HOSPIRA INC | 1996-12-23 | ANDA074632_001 | Atracurium Injection |
| 2 | ANDA074633 | ATRACURIUM BESYLATE PRESERVATIVE FREE | True | HOSPIRA INC | 1996-12-23 | ANDA074633_001 | Atracurium Injection |
| 3 | ANDA074639 | ATRACURIUM BESYLATE PRESERVATIVE FREE | True | HOSPIRA INC | 1997-03-25 | ANDA074639_001 | Atracurium Injection |
| 4 | ANDA074740 | ATRACURIUM BESYLATE | True | HOSPIRA INC | 1997-03-28 | ANDA074740_001 | Atracurium Injection |
| 5 | ANDA074741 | ATRACURIUM BESYLATE PRESERVATIVE FREE | True | HOSPIRA INC | 1997-03-28 | ANDA074741_001 | Atracurium Injection |
| 6 | ANDA074753 | ATRACURIUM BESYLATE | True | BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE | 1997-01-23 | ANDA074753_001 | Atracurium Injection |
| 7 | ANDA074768 | ATRACURIUM BESYLATE PRESERVATIVE FREE | True | BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE | 1997-01-23 | ANDA074768_001 | Atracurium Injection |
| 8 | ANDA074784 | ATRACURIUM BESYLATE | True | TEVA PARENTERAL MEDICINES INC | 1997-06-11 | ANDA074784_001 | Atracurium Injection |
| 9 | ANDA074824 | ATRACURIUM BESYLATE | True | BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE | 1997-09-30 | ANDA074824_001 | Atracurium Injection |
| 10 | ANDA074825 | ATRACURIUM BESYLATE PRESERVATIVE FREE | True | BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE | 1997-09-30 | ANDA074825_001 | Atracurium Injection |
| 11 | ANDA074900 | ATRACURIUM BESYLATE PRESERVATIVE FREE | EUROHEALTH INTERNATIONAL SARL | 1997-07-18 | ANDA074900_001 | Atracurium Injection | |
| 12 | ANDA074901 | ATRACURIUM BESYLATE | EUROHEALTH INTERNATIONAL SARL | 1997-07-18 | ANDA074901_001 | Atracurium Injection | |
| 13 | ANDA074944 | ATRACURIUM BESYLATE PRESERVATIVE FREE | True | WATSON LABORATORIES INC | 1998-07-28 | ANDA074944_001 | Atracurium Injection |
| 14 | ANDA074945 | ATRACURIUM BESYLATE | True | WATSON LABORATORIES INC | 1998-07-28 | ANDA074945_001 | Atracurium Injection |
| 15 | ANDA090761 | ATRACURIUM BESYLATE | HOSPIRA INC | 2012-10-18 | ANDA090761_001 | Atracurium Injection | |
| 16 | ANDA090782 | ATRACURIUM BESYLATE PRESERVATIVE FREE | HOSPIRA INC | 2012-10-18 | ANDA090782_001 | Atracurium Injection | |
| 17 | ANDA091488 | ATRACURIUM BESYLATE PRESERVATIVE FREE | SAGENT PHARMACEUTICALS INC | 2012-02-17 | ANDA091488_001 | Atracurium Injection | |
| 18 | ANDA091489 | ATRACURIUM BESYLATE | SAGENT PHARMACEUTICALS INC | 2012-02-17 | ANDA091489_001 | Atracurium Injection | |
| 19 | ANDA206010 | ATRACURIUM BESYLATE PRESERVATIVE FREE | AUROBINDO PHARMA LTD | 2015-04-08 | ANDA206010_001 | Atracurium Injection | |
| 20 | ANDA206011 | ATRACURIUM BESYLATE | AUROBINDO PHARMA LTD | 2015-04-08 | ANDA206011_001 | Atracurium Injection | |
| 21 | NDA018831 | TRACRIUM | True | HOSPIRA INC | 1983-11-23 | NDA018831_001, NDA018831_002 | Atracurium Injection |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | ANDA074632_001 | discontinued | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | 1996-12-23 | ATRACURIUM BESYLATE | |
| 2 | ANDA074633_001 | discontinued | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | 1996-12-23 | ATRACURIUM BESYLATE PRESERVATIVE FREE | |
| 3 | ANDA074639_001 | discontinued | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | 1997-03-25 | ATRACURIUM BESYLATE PRESERVATIVE FREE | |
| 4 | ANDA074740_001 | discontinued | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | 1997-03-28 | ATRACURIUM BESYLATE | |
| 5 | ANDA074741_001 | discontinued | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | 1997-03-28 | ATRACURIUM BESYLATE PRESERVATIVE FREE | |
| 6 | ANDA074753_001 | discontinued | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | 1997-01-23 | ATRACURIUM BESYLATE | |
| 7 | ANDA074768_001 | discontinued | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | 1997-01-23 | ATRACURIUM BESYLATE PRESERVATIVE FREE | |
| 8 | ANDA074784_001 | discontinued | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | 1997-06-11 | ATRACURIUM BESYLATE | |
| 9 | ANDA074824_001 | discontinued | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | 1997-09-30 | ATRACURIUM BESYLATE | |
| 10 | ANDA074825_001 | discontinued | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | 1997-09-30 | ATRACURIUM BESYLATE PRESERVATIVE FREE | |
| 11 | ANDA074900_001 | RX | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | True | AP | 1997-07-18 | ATRACURIUM BESYLATE PRESERVATIVE FREE |
| 12 | ANDA074901_001 | RX | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | True | AP | 1997-07-18 | ATRACURIUM BESYLATE |
| 13 | ANDA074944_001 | discontinued | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | 1998-07-28 | ATRACURIUM BESYLATE PRESERVATIVE FREE | |
| 14 | ANDA074945_001 | discontinued | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | 1998-07-28 | ATRACURIUM BESYLATE | |
| 15 | ANDA090761_001 | RX | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | AP | 2012-10-18 | ATRACURIUM BESYLATE |
| 16 | ANDA090782_001 | RX | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | AP | 2012-10-18 | ATRACURIUM BESYLATE PRESERVATIVE FREE |
| 17 | ANDA091488_001 | RX | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | AP | 2012-02-17 | ATRACURIUM BESYLATE PRESERVATIVE FREE |
| 18 | ANDA091489_001 | RX | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | AP | 2012-02-17 | ATRACURIUM BESYLATE |
| 19 | ANDA206010_001 | RX | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | AP | 2015-04-08 | ATRACURIUM BESYLATE PRESERVATIVE FREE |
| 20 | ANDA206011_001 | RX | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | AP | 2015-04-08 | ATRACURIUM BESYLATE |
| 21 | NDA018831_001 | discontinued | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | 1983-11-23 | TRACRIUM | |
| 22 | NDA018831_002 | discontinued | ATRACURIUM BESYLATE (10MG/ML) | INJECTION | False | 1985-06-20 | TRACRIUM |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) | in other drug docs |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 5562756e-7475-2d4c-696e-757834416c6c (view SPL) | Atracurium Besylate Injection, USP(For Intravenous Injection) | prescription | Human Prescription | Sagent Pharmaceuticals | 2014-12-22 | 7 | 250210672, 250210659 | Atracurium Injection | |
| 2 | 98ed3c4c-5e53-46c1-8110-6ae41531e36b (view SPL) | Atracurium Besylate Injection, USP(For Intravenous Injection) | prescription | Human Prescription | Sagent Pharmaceuticals | 2015-07-09 | 2 | 250210672, 250210659 | Atracurium Injection | |
| 3 | c3e0a3b9-535d-456b-9a1f-fa18a4d4e38f (view SPL) | prescription | Human Prescription | Aurobindo Pharma Limited | ANALYSIS, MANUFACTURE | 2015-07-29 | 1 | 658620985 | ||
| 4 | de1c2dcd-295b-47ce-b7a1-a8be59939a54 (view SPL) | ATRACURIUM BESYLATE INJECTION USP | prescription | Human Prescription | Hospira, Inc. | 2012-10-22 | 1 | 004091105, 004091109 | Atracurium Injection | |
| 5 | f25cc5a7-0eb0-4902-b402-fe021d7051da (view SPL) | Atracurium Besylate Injection, USP(For Intravenous Injection) | prescription | Human Prescription | Sagent Pharmaceuticals | 2015-07-09 | 5 | 250210672, 250210659 | Atracurium Injection | |
| 6 | f7b6a720-05a7-4d6a-9200-21bdc90fc1c4 (view SPL) | prescription | Human Prescription | Auromedics Pharma Llc | 2015-04-30 | 1 | 551500217 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII