Application 206977

Type: NDA
Sponsor: INSTITUT BIOCHIMIQUE

Related Records

Company: INSTITUT BIOCHIMIQUE

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	13MCG/ML	Yes	No
002	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	25MCG/ML	Yes	No
003	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	50MCG/ML	Yes	No
004	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	75MCG/ML	Yes	No
005	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	88MCG/ML	Yes	No
006	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	100MCG/ML	Yes	No
007	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	112MCG/ML	Yes	No
008	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	125MCG/ML	Yes	No
009	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	137MCG/ML	Yes	No
010	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	150MCG/ML	Yes	No
011	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	175MCG/ML	Yes	No
012	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	200MCG/ML	Yes	Yes
013	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	37.5MCG/ML	Yes	No
014	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	44MCG/ML	Yes	No
015	TIROSINT-SOL	LEVOTHYROXINE SODIUM	SOLUTION;ORAL	62.5MCG/ML	Yes	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0105	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0110	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0112	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0112	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0112	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0112	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0112	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0112	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0113	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0113	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0113	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0113	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0113	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0113	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0115	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0117	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0117	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0117	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0117	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0117	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0117	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0120	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0125	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0130	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0130	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0130	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0130	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0130	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0130	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current
71858-0130	Tirosint	Levothyroxine Sodium	IBSA Pharma Inc.	NDA	Current

Documents

Document	Submission type	Date
76622	SUPPL	2023-11-17
76621	SUPPL	2023-11-17
76597	SUPPL	2023-11-17
76596	SUPPL	2023-11-17
72957	SUPPL	2022-12-20
72952	SUPPL	2022-12-20
48851	ORIG	2017-06-28
47429	SUPPL	2017-03-02
47368	SUPPL	2017-02-28
46423	ORIG	2016-12-21
46215	ORIG	2016-12-19
51311	ORIG	1900-01-01
51310	ORIG	1900-01-01
51309	ORIG	1900-01-01