Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217205
Company: SQUARE PHARMS
Company: SQUARE PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 03/13/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
CALCIUM ACETATE
CAPSULE;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 | CAPSULE;ORAL | Prescription | No | AB | 091312 | CHARTWELL RX |
| CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | No | AB | 202315 | HERITAGE PHARMS INC |
| CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | No | AB | 077728 | HIKMA |
| CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | No | AB | 203135 | INVAGEN PHARMS |
| CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | No | AB | 203179 | MPP PHARMA |
| CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | No | AB | 217205 | SQUARE PHARMS |
| CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | No | AB | 211038 | SUVEN PHARMS |