Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072759
Company: DR REDDYS
Company: DR REDDYS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PANCURONIUM BROMIDE | PANCURONIUM BROMIDE | 1MG/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 |
---|---|---|---|---|---|---|---|
07/31/1990 | 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-26 | Labeling-Package Insert |
Label is not available on this site. |
||
05/10/2012 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
11/22/2010 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
04/24/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
03/29/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
04/18/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/14/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |
PANCURONIUM BROMIDE
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
PANCURONIUM BROMIDE | PANCURONIUM BROMIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 072759 | DR REDDYS |
PANCURONIUM BROMIDE | PANCURONIUM BROMIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 072320 | HOSPIRA |