Application 204982

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 3.75MG BASE;23MG	No	No
002	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 7.5MG BASE;46MG	No	No
003	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 11.25MG BASE;69MG	No	No
004	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 15MG BASE;92MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204982-001	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25
A204982-002	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25
A204982-003	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25
A204982-004	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	PHENTERMINE HYDROCHLORIDE; TOPIRAMATE	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A204982-001	AB
A204982-002	AB
A204982-003	AB
A204982-004	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 · 52 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	A204982-001	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204982-002	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204982-003	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204982-004	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204982-001	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204982-002	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204982-003	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204982-004	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204982-001	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204982-002	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204982-003	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204982-004	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204982-001	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204982-002	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204982-003	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204982-004	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204982-001	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204982-002	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204982-003	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204982-004	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204982-001	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204982-002	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204982-003	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204982-004	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204982-001	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204982-002	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204982-003	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204982-004	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204982-001	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204982-002	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204982-003	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204982-004	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204982-001	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204982-002	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204982-003	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204982-004	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204982-001	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 3.75MG BASE;23MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204982-002	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 7.5MG BASE;46MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204982-003	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 11.25MG BASE;69MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204982-004	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	EQ 15MG BASE;92MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2024-06-25	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 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	A204982-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204982-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204982-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204982-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204982-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204982-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204982-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204982-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204982-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204982-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204982-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204982-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204982-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204982-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204982-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204982-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204982-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204982-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204982-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204982-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204982-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204982-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204982-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204982-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204982-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204982-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204982-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204982-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204982-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204982-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204982-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204982-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204982-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204982-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204982-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204982-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204982-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204982-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204982-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204982-004	AB	1	`d06236e962d9…`

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
Phentermine and topiramate	PHENTERMINE AND TOPIRAMATE	Teva Pharmaceuticals, Inc.	918df93d-e033-4419-adcc-e21655ef8158	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204982 application number: ANDA204982

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82594	SUPPL	2025-06-17
78907	ORIG	2024-06-27