Application 209253

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMPHETAMINE	AMPHETAMINE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	EQ 3.1MG BASE	No	No
002	AMPHETAMINE	AMPHETAMINE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	EQ 6.3MG BASE	No	No
003	AMPHETAMINE	AMPHETAMINE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	EQ 9.4MG BASE	No	No
004	AMPHETAMINE	AMPHETAMINE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	EQ 12.5MG BASE	No	No
005	AMPHETAMINE	AMPHETAMINE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	EQ 15.7MG BASE	No	No
006	AMPHETAMINE	AMPHETAMINE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	EQ 18.8MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209253-001	AMPHETAMINE	AMPHETAMINE	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2023-06-22
A209253-002	AMPHETAMINE	AMPHETAMINE	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2023-06-22
A209253-003	AMPHETAMINE	AMPHETAMINE	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2023-06-22
A209253-004	AMPHETAMINE	AMPHETAMINE	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2023-06-22
A209253-005	AMPHETAMINE	AMPHETAMINE	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2023-06-22
A209253-006	AMPHETAMINE	AMPHETAMINE	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2023-06-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A209253-001	AB
A209253-002	AB
A209253-003	AB
A209253-004	AB
A209253-005	AB
A209253-006	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 3 of 4 · 144 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209253-003	AMPHETAMINE	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209253-004	AMPHETAMINE	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209253-005	AMPHETAMINE	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209253-006	AMPHETAMINE	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209253-001	AMPHETAMINE	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209253-002	AMPHETAMINE	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209253-003	AMPHETAMINE	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209253-004	AMPHETAMINE	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209253-005	AMPHETAMINE	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209253-006	AMPHETAMINE	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209253-001	AMPHETAMINE	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209253-002	AMPHETAMINE	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209253-003	AMPHETAMINE	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209253-004	AMPHETAMINE	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209253-005	AMPHETAMINE	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209253-006	AMPHETAMINE	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209253-001	AMPHETAMINE	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209253-002	AMPHETAMINE	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209253-003	AMPHETAMINE	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209253-004	AMPHETAMINE	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209253-005	AMPHETAMINE	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209253-006	AMPHETAMINE	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209253-001	AMPHETAMINE	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209253-002	AMPHETAMINE	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209253-003	AMPHETAMINE	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209253-004	AMPHETAMINE	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209253-005	AMPHETAMINE	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209253-006	AMPHETAMINE	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209253-001	AMPHETAMINE	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209253-002	AMPHETAMINE	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209253-003	AMPHETAMINE	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209253-004	AMPHETAMINE	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209253-005	AMPHETAMINE	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209253-006	AMPHETAMINE	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL		2023-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209253-001	AMPHETAMINE	EQ 3.1MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2023-06-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209253-002	AMPHETAMINE	EQ 6.3MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2023-06-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209253-003	AMPHETAMINE	EQ 9.4MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2023-06-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209253-004	AMPHETAMINE	EQ 12.5MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2023-06-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209253-005	AMPHETAMINE	EQ 15.7MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2023-06-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209253-006	AMPHETAMINE	EQ 18.8MG BASE	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL	AB	2023-06-22	`ea1830bbd6c7…`

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
2026-10-15 13:18:30	2026-09	A209253-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209253-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209253-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209253-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209253-005	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209253-006	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A209253-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209253-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209253-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209253-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209253-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209253-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209253-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209253-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209253-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209253-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209253-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209253-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209253-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209253-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209253-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209253-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209253-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209253-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209253-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209253-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209253-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209253-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209253-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209253-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209253-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209253-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209253-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209253-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209253-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209253-006	AB	1	`6a471c1ec25d…`
2023-12-20 04:57 UTC	2023-12	A209253-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209253-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209253-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209253-004	AB	1	`ea1830bbd6c7…`

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
Amphetamine	AMPHETAMINE	Teva Pharmaceuticals, Inc.	243e88e7-6621-47e9-8d5c-3f79bcb088bb	2025-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209253 application number: ANDA209253

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
74729	ORIG	2023-07-13