Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019071
Company: MISSION PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
UROCIT-K POTASSIUM CITRATE 5MEQ TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
UROCIT-K POTASSIUM CITRATE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
UROCIT-K POTASSIUM CITRATE 15MEQ TABLET, EXTENDED RELEASE;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
08/30/1985 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/30/2009 SUPPL-12 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019071s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019071s012ltr.pdf
02/13/2002 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/26/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/31/1992 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/30/1992 SUPPL-3 Labeling

Label is not available on this site.

08/31/1992 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/1986 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/30/2009 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019071s012lbl.pdf
12/30/2009 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019071s012lbl.pdf

UROCIT-K

TABLET, EXTENDED RELEASE;ORAL; 5MEQ
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CITRATE POTASSIUM CITRATE 5MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077440 MOUNTAIN
POTASSIUM CITRATE POTASSIUM CITRATE 5MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206813 STRIDES PHARMA
POTASSIUM CITRATE POTASSIUM CITRATE 5MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209758 TEVA PHARMS USA INC
POTASSIUM CITRATE POTASSIUM CITRATE 5MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203546 ZYDUS PHARMS
UROCIT-K POTASSIUM CITRATE 5MEQ TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019071 MISSION PHARMA

TABLET, EXTENDED RELEASE;ORAL; 10MEQ
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CITRATE POTASSIUM CITRATE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB 077440 MOUNTAIN
POTASSIUM CITRATE POTASSIUM CITRATE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206813 STRIDES PHARMA
POTASSIUM CITRATE POTASSIUM CITRATE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209758 TEVA PHARMS USA INC
POTASSIUM CITRATE POTASSIUM CITRATE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203546 ZYDUS PHARMS
UROCIT-K POTASSIUM CITRATE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019071 MISSION PHARMA

TABLET, EXTENDED RELEASE;ORAL; 15MEQ
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
POTASSIUM CITRATE POTASSIUM CITRATE 15MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206813 STRIDES PHARMA
POTASSIUM CITRATE POTASSIUM CITRATE 15MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB 209758 TEVA PHARMS USA INC
POTASSIUM CITRATE POTASSIUM CITRATE 15MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB 203546 ZYDUS PHARMS
UROCIT-K POTASSIUM CITRATE 15MEQ TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 019071 MISSION PHARMA

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