Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209088
Company: AM REGENT
Company: AM REGENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 100MG/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 |
---|---|---|---|---|---|---|---|
07/27/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209088Orig1s000ltr.pdf |
CALCIUM CHLORIDE 10%
INJECTABLE;INJECTION; 100MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CALCIUM CHLORIDE | CALCIUM CHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217524 | AMNEAL |
CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209088 | AM REGENT |
CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 219342 | EXTROVIS |
CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 203477 | INTL MEDICATION SYS |
CALCIUM CHLORIDE 10% | CALCIUM CHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 211553 | MEDEFIL INC |
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER | CALCIUM CHLORIDE | 100MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 021117 | HOSPIRA |