Application 202248

Type: ANDA
Sponsor: ELITE LABS

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 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
A202248-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA		2012-09-28
A202248-002	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA		2012-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202248-001	AA
A202248-002	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 · 82 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	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202248-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-09-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202248-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2012-09-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A202248-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202248-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202248-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202248-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202248-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202248-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202248-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202248-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202248-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202248-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202248-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202248-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202248-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202248-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202248-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202248-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202248-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202248-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202248-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202248-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202248-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202248-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202248-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202248-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202248-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202248-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202248-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202248-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202248-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202248-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202248-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202248-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202248-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202248-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202248-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202248-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202248-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202248-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202248-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202248-002	AA	1	`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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	d95e14f7-a46d-47fa-8dab-ee3d8d4c7b6d	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202248 application number: ANDA202248
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b425840f-380e-42bd-852a-6ee3641977ce	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202248 application number: ANDA202248
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e48feec6-50c9-4ccd-b9da-56956d14c853	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202248 application number: ANDA202248
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	1149f69d-65df-6a98-e063-6394a90aeaa4	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202248 application number: ANDA202248
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	d76940d3-95e6-442d-99ef-4fe92de7a376	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202248 application number: ANDA202248
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Precision Dose Inc.	095a2be5-721e-46e6-976f-9137c855cd22	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202248 application number: ANDA202248
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	723c37c4-868f-40f0-b74d-137dcbb93f9f	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202248 application number: ANDA202248 ndc (product): 63629-1042 ndc (product): 63629-1041
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	8c7c1391-bfd1-48f9-b249-9729fe648b89	2023-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202248 application number: ANDA202248 ndc (product): 50090-2536

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17224-622	Phentermine Hydrochloride	Phentermine Hydrochloride	CALVIN, SCOTT AND COMPANY, INCORPORATED	ANDA	Current
17224-622	Phentermine Hydrochloride	Phentermine Hydrochloride	CALVIN, SCOTT AND COMPANY, INCORPORATED	ANDA	Current
43063-646	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-646	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-646	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-646	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-646	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-646	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-646	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-1534	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-1534	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2536	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2536	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50436-0202	Phentermine Hydrochloride	Phentermine Hydrochloride	UNIT DOSE SERVICES	ANDA	Current
51224-202	Phentermine Hydrochloride	Phentermine Hydrochloride	TAGI Pharma, Inc	ANDA	Current
51224-202	Phentermine Hydrochloride	Phentermine Hydrochloride	TAGI Pharma, Inc	ANDA	Current
51224-203	Phentermine Hydrochloride	Phentermine Hydrochloride	TAGI Pharma, Inc	ANDA	Current
51224-203	Phentermine Hydrochloride	Phentermine Hydrochloride	TAGI Pharma, Inc	ANDA	Current
63629-1040	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1040	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1040	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1041	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1041	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1041	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1042	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1042	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1042	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1043	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1043	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1043	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8152	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8152	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8152	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8152	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68788-7502	Phentermine Hydrochloride	Phentermine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7502	Phentermine Hydrochloride	Phentermine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7502	Phentermine Hydrochloride	Phentermine Hydrochloride	Preferred Pharmaceuticals, Inc.	ANDA	Current
71335-0030	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0030	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0419	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0419	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1591	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current