Application 019211

Type: NDA
Sponsor: HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	40MG/100ML	Yes	No
002	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	80MG/100ML	No	No
003	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	160MG/100ML	Yes	No
004	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	200MG/100ML	No	No
005	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	400MG/100ML	No	No
006	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	320MG/100ML	Yes	No
007	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	INJECTABLE;INJECTION	4MG/ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019211-001	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	40MG/100ML	INJECTABLE / INJECTION	RLD	1984-12-14
N019211-002	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	80MG/100ML	INJECTABLE / INJECTION		1984-12-14
N019211-003	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	160MG/100ML	INJECTABLE / INJECTION	RLD	1984-12-14
N019211-004	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	200MG/100ML	INJECTABLE / INJECTION		1984-12-14
N019211-005	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	400MG/100ML	INJECTABLE / INJECTION		1984-12-14
N019211-006	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	320MG/100ML	INJECTABLE / INJECTION	RLD	1988-01-20
N019211-007	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	THEOPHYLLINE	4MG/ML	INJECTABLE / INJECTION	RLD	1984-12-14

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 8 · 301 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019211-001	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	40MG/100ML	INJECTABLE / INJECTION	RLD	1984-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019211-002	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	80MG/100ML	INJECTABLE / INJECTION		1984-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019211-003	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	160MG/100ML	INJECTABLE / INJECTION	RLD	1984-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019211-004	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION		1984-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019211-005	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION		1984-12-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019211-006	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	320MG/100ML	INJECTABLE / INJECTION	RLD	1988-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019211-007	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	4MG/ML	INJECTABLE / INJECTION	RLD	1984-12-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019211-001	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	40MG/100ML	INJECTABLE / INJECTION	RLD	1984-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019211-002	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	80MG/100ML	INJECTABLE / INJECTION		1984-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019211-003	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	160MG/100ML	INJECTABLE / INJECTION	RLD	1984-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019211-004	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION		1984-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019211-005	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION		1984-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019211-006	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	320MG/100ML	INJECTABLE / INJECTION	RLD	1988-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019211-007	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	4MG/ML	INJECTABLE / INJECTION	RLD	1984-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019211-001	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	40MG/100ML	INJECTABLE / INJECTION	RLD	1984-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019211-002	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	80MG/100ML	INJECTABLE / INJECTION		1984-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019211-003	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	160MG/100ML	INJECTABLE / INJECTION	RLD	1984-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019211-004	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION		1984-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019211-005	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION		1984-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019211-006	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	320MG/100ML	INJECTABLE / INJECTION	RLD	1988-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019211-007	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	4MG/ML	INJECTABLE / INJECTION	RLD	1984-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019211-001	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	40MG/100ML	INJECTABLE / INJECTION	RLD	1984-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019211-002	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	80MG/100ML	INJECTABLE / INJECTION		1984-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019211-003	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	160MG/100ML	INJECTABLE / INJECTION	RLD	1984-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019211-004	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION		1984-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019211-005	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION		1984-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019211-006	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	320MG/100ML	INJECTABLE / INJECTION	RLD	1988-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019211-007	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	4MG/ML	INJECTABLE / INJECTION	RLD	1984-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019211-001	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	40MG/100ML	INJECTABLE / INJECTION	RLD	1984-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019211-002	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	80MG/100ML	INJECTABLE / INJECTION		1984-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019211-003	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	160MG/100ML	INJECTABLE / INJECTION	RLD	1984-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019211-004	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION		1984-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019211-005	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION		1984-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019211-006	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	320MG/100ML	INJECTABLE / INJECTION	RLD	1988-01-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019211-007	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	4MG/ML	INJECTABLE / INJECTION	RLD	1984-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019211-001	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	40MG/100ML	INJECTABLE / INJECTION	RLD	1984-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019211-002	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	80MG/100ML	INJECTABLE / INJECTION		1984-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019211-003	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	160MG/100ML	INJECTABLE / INJECTION	RLD	1984-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019211-004	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML	INJECTABLE / INJECTION		1984-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019211-005	THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/100ML	INJECTABLE / INJECTION		1984-12-14	`fd3edfee7708…`

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theophylline	THEOPHYLLINE	PD-Rx Pharmaceuticals, Inc.	c6ca5cc9-4e5e-40cf-a36e-227aa4cb55c6	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	PD-Rx Pharmaceuticals, Inc.	5e64036a-ee3e-42e7-9e59-881f88a4e298	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline (Anhydrous)	THEOPHYLLINE	Golden State Medical Supply, Inc.	aa80b9f4-8a5d-3e14-e053-2a95a90a8aab	2026-05-27	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Strides Pharma Science Limited	b7a90ccf-9c32-40cc-9008-7e55b3da4dfd	2026-03-10	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Chartwell RX, LLC	1b685384-5d96-46fa-b93b-e96538a2cfe7	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Glenmark Pharmaceuticals Inc., USA	48330a8e-be08-4d38-b8b1-d30fbd5a35de	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Glenmark Pharmaceuticals Inc., USA	56fc2167-ceb6-4e3e-8ff7-5e400dfbd533	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	AvKARE	f93e20b1-97aa-088d-e053-6394a90a25d4	2026-01-19	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Chartwell RX, LLC	9591d4db-2b88-4f0f-b61e-64ba67626e3d	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	ATLANTIC BIOLOGICALS CORP.	47e484c2-f59e-4a71-bb97-c90f128ac345	2025-12-04	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Ajanta Pharma USA Inc.	7a422c32-bbdf-4297-84f4-9c438c904b0c	2025-11-30	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Chartwell Governmental & Specialty RX, LLC.	e2716dac-8b23-4e06-bc3e-4dd76b7c813e	2025-11-14	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Bryant Ranch Prepack	62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd	2025-10-22	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	701fbf9c-e06b-46f4-863b-981acf3021aa	2025-07-10	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Bryant Ranch Prepack	955dba5e-c3b7-4a45-8650-e1b4722dbaea	2024-11-20	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
THEOPHYLLINE	THEOPHYLLINE	PAI Holdings, LLC dba PAI Pharma	32b9780f-c46f-4e0f-9641-2cab60600e6e	2024-11-19	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
THEOPHYLLINE	THEOPHYLLINE	Leading Pharma, LLC	ac490ebf-24e1-47c4-a932-ad4dcafe7aad	2024-10-07	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Cranbury Pharmaceuticals, LLC	78a99bfe-6ebe-4ace-80b0-ee019921435e	2024-08-30	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Viona Pharmaceuticals Inc	abdfb9b9-9402-4761-9347-8eb1c4d86242	2024-05-22	Warnings, Adverse reactions	Name fallback generic name: THEOPHYLLINE
Theophylline	THEOPHYLLINE	Zydus Lifesciences Limited	7339f98d-b996-4e20-a7a7-315fd2a9fa4d	2024-05-22		Name fallback generic name: THEOPHYLLINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
11452	SUPPL	2009-04-03
1252	SUPPL	2009-04-01
11451	SUPPL	2008-11-07
16214	SUPPL	2008-11-03