Application 019071

Type: NDA
Sponsor: MISSION PHARMA

Related Records

Company: MISSION PHARMA

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	UROCIT-K	POTASSIUM CITRATE	TABLET, EXTENDED RELEASE;ORAL	5MEQ	Yes	No
002	UROCIT-K	POTASSIUM CITRATE	TABLET, EXTENDED RELEASE;ORAL	10MEQ	Yes	No
003	UROCIT-K	POTASSIUM CITRATE	TABLET, EXTENDED RELEASE;ORAL	15MEQ	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0600	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0610	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0178-0615	UROCIT-K	potassium citrate	Mission Pharmacal Company	NDA	Current
0245-0070	Potassium Citrate	potassium citrate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0070	Potassium Citrate	potassium citrate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0070	Potassium Citrate	potassium citrate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0071	Potassium Citrate	potassium citrate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0071	Potassium Citrate	potassium citrate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-0071	Potassium Citrate	potassium citrate	Upsher-Smith Laboratories, LLC	NDA	Current
44523-415	Potassium Citrate	potassium citrate	Biocomp Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
44523-415	Potassium Citrate	potassium citrate	Biocomp Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
44523-415	Potassium Citrate	potassium citrate	Biocomp Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
44523-415	Potassium Citrate	potassium citrate	Biocomp Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
70518-0086	UROCIT-K	potassium citrate	REMEDYREPACK INC.	NDA	Current

Documents

Document	Submission type	Date
69576	SUPPL	2021-12-16
69550	SUPPL	2021-12-14
16186	SUPPL	2010-01-08
11432	SUPPL	2010-01-08