Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074900
Company: HIKMA
Company: HIKMA
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/18/1997 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/26/2018 | SUPPL-20 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
11/23/2010 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
03/26/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
04/03/2001 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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06/27/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
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 |