Application 201525

Type: NDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOCETAXEL	DOCETAXEL	INJECTABLE;INJECTION	20MG/2ML (10MG/ML)	No	No
002	DOCETAXEL	DOCETAXEL	INJECTABLE;INJECTION	80MG/8ML (10MG/ML)	No	No
003	DOCETAXEL	DOCETAXEL	INJECTABLE;INJECTION	160MG/16ML (10MG/ML)	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43066-001	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-001	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-001	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-001	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-001	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-001	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-001	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-006	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-006	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-006	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-006	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-006	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-006	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-006	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-010	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-010	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-010	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-010	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-010	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-010	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
43066-010	Docetaxel	docetaxel	Baxter Healthcare Corporation	NDA	Current
66758-050	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-050	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-050	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-050	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-050	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-050	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-050	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-050	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-950	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-950	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-950	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-950	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-950	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-950	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current
66758-950	Docetaxel	docetaxel	Sandoz Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75561	SUPPL	2023-09-25
75533	SUPPL	2023-09-22
65904	SUPPL	2021-01-14
65902	SUPPL	2021-01-14
64267	SUPPL	2020-08-12
64266	SUPPL	2020-08-12
61530	SUPPL	2020-01-07
61514	SUPPL	2020-01-06
59615	SUPPL	2019-08-07
58137	SUPPL	2019-03-29
58136	SUPPL	2019-03-29
58134	SUPPL	2019-03-28
58133	SUPPL	2019-03-28
45636	SUPPL	2016-10-25
19023	SUPPL	2014-11-07
19022	SUPPL	2014-11-07
32115	SUPPL	2014-11-05
9902	SUPPL	2014-11-05
19021	SUPPL	2014-04-25
9901	SUPPL	2014-04-24
9900	SUPPL	2012-03-19
19020	SUPPL	2012-03-16
43368	ORIG	2012-01-12
24395	ORIG	2012-01-12
9899	ORIG	2011-07-06
19019	ORIG	2011-06-30

Application 201525

Related Records#

Application Products#

NDC Listings For This Application#

Documents#