Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021160
Company: FRESENIUS MEDCL
Company: FRESENIUS MEDCL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PHOSLO | CALCIUM ACETATE | 333.5MG | CAPSULE;ORAL | Discontinued | None | No | No |
PHOSLO | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Discontinued | None | No | No |
PHOSLO GELCAPS | CALCIUM ACETATE | 667MG | CAPSULE;ORAL | Prescription | AB | Yes | 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 |
---|---|---|---|---|---|---|---|
04/02/2001 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21160lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21160ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021160_Phoslo.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/22/2016 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/24/2016 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/12/2016 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/27/2014 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/29/2015 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/12/2013 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/21/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/29/2011 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021160s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021160s015ltr.pdf | |
02/02/2004 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19976slr006,21160slr001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/29/2011 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021160s015lbl.pdf | |
04/02/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21160lbl.pdf |
PHOSLO
There are no Therapeutic Equivalents.
PHOSLO GELCAPS
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 | 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 | 211038 | SUVEN PHARMS |
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