Application 205555

Type: NDA
Sponsor: NOVATECH SA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STERITALC	TALC	POWDER;INTRAPLEURAL	2GM/VIAL	Yes	No
002	STERITALC	TALC	POWDER;INTRAPLEURAL	3GM/VIAL	Yes	No
003	STERITALC	TALC	POWDER;INTRAPLEURAL	4GM/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N205555-001	STERITALC	TALC	2GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01
N205555-002	STERITALC	TALC	3GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01
N205555-003	STERITALC	TALC	4GM/VIAL	POWDER / INTRAPLEURAL	RLD, RS	2017-05-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205555-001	STERITALC	2GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205555-002	STERITALC	3GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205555-003	STERITALC	4GM/VIAL	POWDER / INTRAPLEURAL	RLD, RS	2017-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205555-001	STERITALC	2GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205555-002	STERITALC	3GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205555-003	STERITALC	4GM/VIAL	POWDER / INTRAPLEURAL	RLD, RS	2017-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205555-001	STERITALC	2GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205555-002	STERITALC	3GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205555-003	STERITALC	4GM/VIAL	POWDER / INTRAPLEURAL	RLD, RS	2017-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205555-001	STERITALC	2GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205555-002	STERITALC	3GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205555-003	STERITALC	4GM/VIAL	POWDER / INTRAPLEURAL	RLD, RS	2017-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205555-001	STERITALC	2GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205555-002	STERITALC	3GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205555-003	STERITALC	4GM/VIAL	POWDER / INTRAPLEURAL	RLD, RS	2017-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205555-001	STERITALC	2GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205555-002	STERITALC	3GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205555-003	STERITALC	4GM/VIAL	POWDER / INTRAPLEURAL	RLD, RS	2017-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205555-001	STERITALC	2GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205555-002	STERITALC	3GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205555-003	STERITALC	4GM/VIAL	POWDER / INTRAPLEURAL	RLD, RS	2017-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205555-001	STERITALC	2GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205555-002	STERITALC	3GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205555-003	STERITALC	4GM/VIAL	POWDER / INTRAPLEURAL	RLD, RS	2017-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205555-001	STERITALC	2GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205555-002	STERITALC	3GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205555-003	STERITALC	4GM/VIAL	POWDER / INTRAPLEURAL	RLD, RS	2017-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205555-001	STERITALC	2GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205555-002	STERITALC	3GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205555-003	STERITALC	4GM/VIAL	POWDER / INTRAPLEURAL	RLD, RS	2017-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205555-001	STERITALC	2GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205555-002	STERITALC	3GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205555-003	STERITALC	4GM/VIAL	POWDER / INTRAPLEURAL	RLD, RS	2017-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205555-001	STERITALC	2GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205555-002	STERITALC	3GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205555-003	STERITALC	4GM/VIAL	POWDER / INTRAPLEURAL	RLD, RS	2017-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205555-001	STERITALC	2GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205555-002	STERITALC	3GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205555-003	STERITALC	4GM/VIAL	POWDER / INTRAPLEURAL	RLD, RS	2017-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205555-001	STERITALC	2GM/VIAL	POWDER / INTRAPLEURAL	RLD	2017-05-01	`8072bd15b7f6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205555-001	ODE-143	2024-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205555-001	ODE-191	2024-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205555-002	ODE-143	2024-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205555-002	ODE-191	2024-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205555-003	ODE-143	2024-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205555-003	ODE-191	2024-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205555-001	ODE-143	2024-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205555-001	ODE-191	2024-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205555-002	ODE-143	2024-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205555-002	ODE-191	2024-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205555-003	ODE-143	2024-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205555-003	ODE-191	2024-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205555-001	ODE-143	2024-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205555-001	ODE-191	2024-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205555-002	ODE-143	2024-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205555-002	ODE-191	2024-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205555-003	ODE-143	2024-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205555-003	ODE-191	2024-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205555-001	ODE-143	2024-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205555-001	ODE-191	2024-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205555-002	ODE-143	2024-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205555-002	ODE-191	2024-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205555-003	ODE-143	2024-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205555-003	ODE-191	2024-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205555-001	ODE-143	2024-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205555-001	ODE-191	2024-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205555-002	ODE-143	2024-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205555-002	ODE-191	2024-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205555-003	ODE-143	2024-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205555-003	ODE-191	2024-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205555-001	ODE-143	2024-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205555-001	ODE-191	2024-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205555-002	ODE-143	2024-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205555-002	ODE-191	2024-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205555-003	ODE-143	2024-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205555-003	ODE-191	2024-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205555-001	ODE-143	2024-05-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205555-001	ODE-191	2024-05-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205555-002	ODE-143	2024-05-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205555-002	ODE-191	2024-05-01	`301d65b070ca…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Steritalc 2g	TALC	Novatech SA	c94e51d9-beef-4b06-e053-2a95a90a754a	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205555 application number: NDA205555 ndc (product): 62327-333 ndc (product): 62327-222 ndc (product): 62327-444

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62327-222	Steritalc	Talc	Novatech SA	NDA	Current
62327-222	Steritalc	Talc	Novatech SA	NDA	Current
62327-333	Steritalc	Talc	Novatech SA	NDA	Current
62327-333	Steritalc	Talc	Novatech SA	NDA	Current
62327-444	Steritalc	Talc	Novatech SA	NDA	Current
62327-444	Steritalc	Talc	Novatech SA	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82543	SUPPL	2025-06-12
82532	SUPPL	2025-06-11
49867	ORIG	2017-09-27
48284	ORIG	2017-05-08
48236	ORIG	2017-05-04