Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091488
Company: MEITHEAL
Company: MEITHEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ATRACURIUM BESYLATE PRESERVATIVE FREE | ATRACURIUM BESYLATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
02/17/2012 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091488Orig1s000Approv.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/26/2018 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
ATRACURIUM BESYLATE PRESERVATIVE FREE
INJECTABLE;INJECTION; 10MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ATRACURIUM BESYLATE | ATRACURIUM BESYLATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206011 | EUGIA PHARMA |
ATRACURIUM BESYLATE | ATRACURIUM BESYLATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074901 | HIKMA |
ATRACURIUM BESYLATE | ATRACURIUM BESYLATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090761 | HOSPIRA INC |
ATRACURIUM BESYLATE | ATRACURIUM BESYLATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091489 | MEITHEAL |
ATRACURIUM BESYLATE PRESERVATIVE FREE | ATRACURIUM BESYLATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206010 | EUGIA PHARMA |
ATRACURIUM BESYLATE PRESERVATIVE FREE | ATRACURIUM BESYLATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074900 | HIKMA |
ATRACURIUM BESYLATE PRESERVATIVE FREE | ATRACURIUM BESYLATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090782 | HOSPIRA INC |
ATRACURIUM BESYLATE PRESERVATIVE FREE | ATRACURIUM BESYLATE | 10MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091488 | MEITHEAL |