Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205656
Company: GLAND PHARMA LTD
Company: GLAND PHARMA LTD
| 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 |
|---|---|---|---|---|---|---|---|
| 04/04/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/05/2020 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/05/2020 | 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 | 206206 | AUROBINDO PHARMA LTD |
| 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 | 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 | 091458 | SAGENT PHARMS INC |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 50MG/5ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 079195 | SANDOZ INC |
| 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 | 206206 | AUROBINDO PHARMA LTD |
| 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 | 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 | 091458 | SAGENT PHARMS INC |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | 100MG/10ML (10MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 079195 | SANDOZ INC |
| 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 |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English