Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091312
Company: CHARTWELL RX
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
06/01/2012 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
11/20/2018 SUPPL-1 Labeling-Package Insert

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 201658 AMNEAL PHARMS
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 203298 LOTUS PHARM CO LTD
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
PHOSLO GELCAPS CALCIUM ACETATE 667MG CAPSULE;ORAL Prescription Yes AB 021160 FRESENIUS MEDCL

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English