Application 200272

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	TABLET;ORAL	37.5MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200272-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA		2011-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200272-001	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 2 · 41 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	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A200272-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200272-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200272-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200272-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200272-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200272-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200272-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200272-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200272-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200272-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200272-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200272-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200272-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200272-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200272-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200272-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200272-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200272-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200272-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200272-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200272-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200272-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200272-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200272-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200272-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200272-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200272-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200272-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200272-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200272-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200272-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200272-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200272-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200272-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200272-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200272-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200272-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200272-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200272-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200272-001	AA	1	`cb3db0bc1861…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	19f1ce79-65f4-4bf4-a9ff-6ca0a131530f	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e6939fcf-3db2-492a-99ed-a384cdeea7a2	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	328d6a39-34f4-4b74-a1bf-6ec6005b1322	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272 ndc (product): 63629-2477
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	TAGI Pharma, Inc.	1993b181-f4f1-4451-92a0-7ed8f32598ba	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272 ndc (product): 51224-101
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Precision Dose Inc.	8d5697b9-02e8-40c4-97c7-761d635243c8	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	f3b43443-dcf3-4a0d-a919-1be1bb9495ed	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	30b48126-45f3-21fa-e063-6294a90a968f	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine HCL	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	8fe6b65d-ca61-40f0-90fc-255dfd075611	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	bd7393cb-2b72-4ecd-ba03-801b635b7647	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272 ndc (product): 71335-0161
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	707af68e-1630-4f86-87ba-1a643d2b4ef9	2023-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-437	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, In	ANDA	Current
43063-437	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-437	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-437	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-437	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-437	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-437	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50436-0101	Phentermine Hydrochloride	Phentermine Hydrochloride	Unit Dose Services	ANDA	Current
51224-101	Phentermine Hydrochloride	Phentermine Hydrochloride	TAGI Pharma, Inc.	ANDA	Current
51224-101	Phentermine Hydrochloride	Phentermine Hydrochloride	TAGI Pharma, Inc.	ANDA	Current
63629-1044	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1044	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1044	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1044	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1045	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1045	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1045	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2477	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2477	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8201	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
69677-293	Phentermine Hydrochloride	Phentermine Hydrochloride	Mas Management Group, Inc.	ANDA	Current
71335-0161	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0161	Phentermine Hydrochloride	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72789-208	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-208	Phentermine Hydrochloride	Phentermine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current