Application 205433

Type: NDA
Sponsor: PULMOFLOW INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KITABIS PAK	TOBRAMYCIN	SOLUTION;INHALATION	300MG/5ML	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205433-001	KITABIS PAK	TOBRAMYCIN	300MG/5ML	SOLUTION / INHALATION	AN		2014-12-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N205433-001	AN

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205433-001	KITABIS PAK	300MG/5ML	SOLUTION / INHALATION	AN	2014-12-02	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205433-001	AN	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205433-001	AN	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205433-001	AN	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205433-001	AN	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205433-001	AN	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205433-001	AN	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205433-001	AN	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205433-001	AN	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205433-001	AN	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205433-001	AN	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205433-001	AN	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205433-001	AN	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205433-001	AN	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205433-001	AN	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205433-001	AN	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205433-001	AN	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205433-001	AN	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205433-001	AN	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205433-001	AN	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205433-001	AN	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205433-001	AN	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205433-001	AN	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205433-001	AN	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205433-001	AN	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205433-001	AN	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205433-001	AN	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205433-001	AN	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205433-001	AN	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205433-001	AN	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205433-001	AN	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205433-001	AN	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205433-001	AN	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205433-001	AN	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205433-001	AN	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205433-001	AN	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205433-001	AN	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205433-001	AN	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205433-001	AN	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205433-001	AN	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205433-001	AN	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tobramycin Inhalation Solution Pak	TOBRAMYCIN	Genericus, Inc.	dad13445-f591-4829-96f9-1598ba03dff8	2024-12-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205433 application number: NDA205433 ndc (product): 70644-899
Kitabis Pak	TOBRAMYCIN	Pari Respiratory Equipment, Inc.	da1e5afd-d707-4af1-8935-8195ba6d769f	2024-11-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205433 application number: NDA205433 ndc (product): 24492-850

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24492-850	Kitabis Pak	Tobramycin	Pari Respiratory Equipment	NDA	Current
24492-850	Kitabis Pak	Tobramycin	Pari Respiratory Equipment, Inc.	NDA	Current
24492-850	Kitabis Pak	Tobramycin	Pari Respiratory Equipment	NDA	Current
24492-850	Kitabis Pak	Tobramycin	Pari Respiratory Equipment, Inc.	NDA	Current
24492-850	Kitabis Pak	Tobramycin	Pari Respiratory Equipment	NDA	Current
70644-899	Tobramycin	Tobramycin	Genericus, Inc.	NDA AUTHORIZED GENERIC	Current
70644-899	Tobramycin	Tobramycin	Genericus, Inc.	NDA AUTHORIZED GENERIC	Current
70644-899	Tobramycin	Tobramycin	Genericus, Inc.	NDA AUTHORIZED GENERIC	Current
70644-899	Tobramycin	Tobramycin	Genericus, Inc.	NDA AUTHORIZED GENERIC	Current
70644-899	Tobramycin	Tobramycin	Genericus, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73984	SUPPL	2023-04-12
73971	SUPPL	2023-04-11
73476	SUPPL	2023-02-13
73466	SUPPL	2023-02-13
61206	SUPPL	2019-12-10
61200	SUPPL	2019-12-09
22987	ORIG	2015-04-06
32671	ORIG	2014-12-03
19644	ORIG	2014-12-03
32672	ORIG	2014-08-27