Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202127
Company: LUPIN LTD
Company: LUPIN LTD
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 |
---|---|---|---|---|---|---|---|
07/09/2015 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202127Orig1s000ltr.pdf |
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 | 202127 | LUPIN LTD |
CALCIUM ACETATE | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | No | AB | 203179 | NOSTRUM LABS INC |
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 |