Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 079195
Company: SANDOZ
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (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 |
---|---|---|---|---|---|---|---|
12/05/2008 | 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 |
---|---|---|---|---|---|
06/20/2023 | SUPPL-22 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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05/03/2019 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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07/26/2018 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels |
Label is not available on this site. |
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10/16/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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02/12/2013 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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05/24/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
ROCURONIUM BROMIDE
INJECTABLE;INJECTION; 50MG/5ML (10MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 216234 | CAPLIN |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 206206 | EUGIA PHARMA |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078651 | FRESENIUS KABI USA |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 205656 | GLAND PHARMA LTD |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078519 | HOSPIRA |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213453 | MEITHEAL |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 079199 | MYLAN INSTITUTIONAL |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210437 | PIRAMAL CRITICAL |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 212668 | PRINSTON INC |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091458 | SAGENT PHARMS INC |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 079195 | SANDOZ |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 215684 | SHANDONG |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 217092 | STERISCIENCE |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091115 | TAMARANG |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 204679 | WEST WARD PHARM CORP |
INJECTABLE;INJECTION; 100MG/10ML (10MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 216234 | CAPLIN |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 206206 | EUGIA PHARMA |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078651 | FRESENIUS KABI USA |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 205656 | GLAND PHARMA LTD |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 078519 | HOSPIRA |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 213453 | MEITHEAL |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 079199 | MYLAN INSTITUTIONAL |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 210437 | PIRAMAL CRITICAL |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 212668 | PRINSTON INC |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091458 | SAGENT PHARMS INC |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 079195 | SANDOZ |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 215684 | SHANDONG |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091115 | TAMARANG |
ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 204679 | WEST WARD PHARM CORP |