Application 016677

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	900MG/100ML	Yes	Yes
003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	SOLUTION;INJECTION	450MG/50ML (9MG/ML)	Yes	Yes
004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	9MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	RLD / RS	Approval date
N016677-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982
N016677-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982
N016677-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	225MG/25ML (9MG/ML)	SOLUTION / INJECTION		RLD, RS	1985-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N016677-001	AP
N016677-003	AP

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 3 · 106 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N016677-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016677-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016677-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	225MG/25ML (9MG/ML)	SOLUTION / INJECTION		RLD, RS	1985-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016677-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016677-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016677-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	225MG/25ML (9MG/ML)	SOLUTION / INJECTION		RLD, RS	1985-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016677-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016677-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016677-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	225MG/25ML (9MG/ML)	SOLUTION / INJECTION		RLD, RS	1985-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016677-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016677-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016677-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	225MG/25ML (9MG/ML)	SOLUTION / INJECTION		RLD, RS	1985-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016677-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016677-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016677-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	225MG/25ML (9MG/ML)	SOLUTION / INJECTION		RLD, RS	1985-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016677-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016677-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016677-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	225MG/25ML (9MG/ML)	SOLUTION / INJECTION		RLD, RS	1985-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016677-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016677-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016677-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	225MG/25ML (9MG/ML)	SOLUTION / INJECTION		RLD, RS	1985-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016677-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016677-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016677-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	225MG/25ML (9MG/ML)	SOLUTION / INJECTION		RLD, RS	1985-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016677-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016677-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016677-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	225MG/25ML (9MG/ML)	SOLUTION / INJECTION		RLD, RS	1985-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016677-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016677-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016677-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	225MG/25ML (9MG/ML)	SOLUTION / INJECTION		RLD, RS	1985-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016677-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016677-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016677-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	225MG/25ML (9MG/ML)	SOLUTION / INJECTION		RLD, RS	1985-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016677-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016677-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016677-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	225MG/25ML (9MG/ML)	SOLUTION / INJECTION		RLD, RS	1985-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016677-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016677-003	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016677-004	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	225MG/25ML (9MG/ML)	SOLUTION / INJECTION		RLD, RS	1985-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016677-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS, Approved before 1982		`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N016677-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016677-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016677-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016677-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016677-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016677-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016677-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016677-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016677-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016677-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016677-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016677-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016677-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016677-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016677-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016677-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016677-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016677-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016677-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016677-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016677-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016677-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016677-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016677-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016677-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016677-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016677-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016677-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016677-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016677-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016677-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016677-004	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016677-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016677-004	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016677-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016677-004	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016677-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016677-004	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016677-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016677-004	AP	1	`bb7c543d1eb4…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sodium Chloride	SODIUM CHLORIDE	Sportpharm LLC	a2c111f6-74d5-4a5d-82ac-d0f237488cb8	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016677 application number: NDA016677
Sodium Chloride	SODIUM CHLORIDE	ProPharma Distribution	3f79fb8b-d0e8-db2a-e063-6394a90ac136	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016677 application number: NDA016677
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	958d35f0-6834-43be-a700-fa58f38b4c19	2025-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016677 application number: NDA016677 ndc (product): 0338-9543
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	f55bd888-5e01-474d-871b-24654c070178	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016677 application number: NDA016677 ndc (product): 0338-0049

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0049	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0049	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0049	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0049	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0049	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0049	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0049	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-9529	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9529	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9529	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9529	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9529	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9529	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9537	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9537	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9537	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9537	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9537	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9537	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9543	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9543	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9543	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9543	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9543	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9543	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9543	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
49836-031	LIQUIVIDA HYDRATION	SODIUM CHLORIDE	RX PHARMA-PACK, INC.	NDA	Current
49836-031	LIQUIVIDA HYDRATION	SODIUM CHLORIDE	RX PHARMA-PACK, INC.	NDA	Current
49836-032	LIQUIVIDA HYDRATION	SODIUM CHLORIDE, CHLORHEXIDINE GLUCONATE , ISOPROPYL ALCOHOL	RX PHARMA-PACK, INC.	NDA	Current
49836-032	LIQUIVIDA HYDRATION	SODIUM CHLORIDE, CHLORHEXIDINE GLUCONATE , ISOPROPYL ALCOHOL	RX PHARMA-PACK, INC.	NDA	Current
49836-032	LIQUIVIDA HYDRATION	SODIUM CHLORIDE, CHLORHEXIDINE GLUCONATE , ISOPROPYL ALCOHOL	RX PHARMA-PACK, INC.	NDA	Current
70529-022	Nacellate Solution 0.9% - 250mL	Sodium Chloride	IT3 Medical LLC	NDA	Current
70529-022	Nacellate Solution 0.9% - 250mL	Sodium Chloride	IT3 Medical LLC	NDA	Current
70529-022	Nacellate Solution 0.9% - 250mL	Sodium Chloride	IT3 Medical LLC	NDA	Current
70529-023	Nacellate Solution 0.9% - 500mL	Sodium Chloride	IT3 Medical LLC	NDA	Current
70529-023	Nacellate Solution 0.9% - 500mL	Sodium Chloride	IT3 Medical LLC	NDA	Current
70529-023	Nacellate Solution 0.9% - 500mL	Sodium Chloride	IT3 Medical LLC	NDA	Current
70529-024	Nacellate Solution 0.9% - 1000mL	Sodium Chloride	IT3 Medical LLC	NDA	Current
70529-024	Nacellate Solution 0.9% - 1000mL	Sodium Chloride	IT3 Medical LLC	NDA	Current
70529-024	Nacellate Solution 0.9% - 1000mL	Sodium Chloride	IT3 Medical LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79224	SUPPL	2024-07-29
79212	SUPPL	2024-07-25
58966	SUPPL	2019-06-04
58891	SUPPL	2019-05-30
53075	SUPPL	2018-03-21
53074	SUPPL	2018-03-21
10909	SUPPL	2015-06-03
10908	SUPPL	2015-01-08
475	SUPPL	2014-12-30
10907	SUPPL	2013-09-17
474	SUPPL	2013-09-13
10906	SUPPL	2005-09-07
473	SUPPL	2005-09-07
33189	SUPPL	2005-05-25
13015	SUPPL	2005-05-25
13014	SUPPL	2003-07-28
13013	SUPPL	2002-04-03