Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202420
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CALCIUM ACETATE | CALCIUM ACETATE | 667MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
02/05/2013 | ORIG-1 | Approval |
Label is not available on this site. |
CALCIUM ACETATE
TABLET;ORAL; 667MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CALCIUM ACETATE | CALCIUM ACETATE | 667MG | TABLET;ORAL | Prescription | No | AB | 202420 | CHARTWELL MOLECULAR |
CALCIUM ACETATE | CALCIUM ACETATE | 667MG | TABLET;ORAL | Prescription | No | AB | 202885 | HERITAGE PHARMS INC |
CALCIUM ACETATE | CALCIUM ACETATE | 667MG | TABLET;ORAL | Prescription | No | AB | 091561 | PADAGIS US |