Application 212184

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THEOPHYLLINE	THEOPHYLLINE	TABLET, EXTENDED RELEASE;ORAL	300MG	No	No
002	THEOPHYLLINE	THEOPHYLLINE	TABLET, EXTENDED RELEASE;ORAL	450MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212184-001	THEOPHYLLINE	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-06-03
A212184-002	THEOPHYLLINE	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB		2021-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212184-001	AB
A212184-002	AB

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 · 66 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	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212184-001	THEOPHYLLINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212184-002	THEOPHYLLINE	450MG	TABLET, EXTENDED RELEASE / ORAL	AB	2021-06-03	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 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	A212184-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212184-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212184-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212184-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212184-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212184-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212184-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212184-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212184-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212184-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212184-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212184-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212184-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212184-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212184-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212184-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212184-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212184-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212184-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212184-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212184-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212184-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212184-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212184-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212184-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212184-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212184-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212184-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212184-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212184-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212184-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212184-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212184-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212184-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212184-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212184-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212184-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212184-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212184-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212184-002	AB	1	`6a51e52b5d6a…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A212184-002	CGT	2021-12-08	`782e0a99824c…`

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
Theophylline	THEOPHYLLINE	Glenmark Pharmaceuticals Inc., USA	48330a8e-be08-4d38-b8b1-d30fbd5a35de	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212184 application number: ANDA212184 ndc (product): 68462-721 ndc (product): 68462-722

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68462-721	Theophylline	Theophylline	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-722	Theophylline	Theophylline	Glenmark Pharmaceuticals Inc., USA	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68441	ORIG	2021-08-23
68026	ORIG	2021-07-07