Application 204318

Type: ANDA
Sponsor: AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	CAPSULE;ORAL	15MG	No	No
002	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	CAPSULE;ORAL	30MG	No	No

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

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
A204318-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA		2016-11-09
A204318-002	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA		2016-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204318-001	AA
A204318-002	AA

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 · 84 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
2026-08-18 06:07:40	2026-07	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`bb7c543d1eb4…`

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	A204318-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204318-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204318-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204318-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204318-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204318-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204318-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204318-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204318-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204318-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204318-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204318-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204318-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204318-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204318-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204318-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204318-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204318-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204318-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204318-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204318-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204318-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204318-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204318-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204318-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204318-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204318-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204318-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204318-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204318-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204318-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204318-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204318-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204318-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204318-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204318-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204318-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204318-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204318-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204318-002	AA	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine	PHENTERMINE HYDROCHLORIDE	Aurolife Pharma, LLC	737eef3b-9a6b-4ab3-a25c-49d84d2a0197	2019-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204318 application number: ANDA204318 ndc (product): 13107-106 ndc (product): 13107-105

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13107-105	Phentermine	Phentermine Hydrochloride	Aurolife Pharma, LLC	ANDA	Current
13107-106	Phentermine	Phentermine Hydrochloride	Aurolife Pharma, LLC	ANDA	Current
50090-3282	Phentermine	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3282	Phentermine	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3282	Phentermine	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3306	Phentermine	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3306	Phentermine	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
68788-7691	Phentermine	Phentermine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current