Application 203068

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	TABLET;ORAL	37.5MG	No	No

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

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
A203068-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA		2014-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203068-001	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 · 42 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	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A203068-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203068-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203068-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203068-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203068-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203068-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203068-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203068-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203068-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203068-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203068-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203068-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203068-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203068-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203068-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203068-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203068-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203068-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203068-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203068-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203068-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203068-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203068-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203068-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203068-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203068-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203068-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203068-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203068-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203068-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203068-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203068-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203068-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203068-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203068-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203068-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203068-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203068-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203068-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203068-001	AA	1	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	Aurolife Pharma LLC	5927e0f6-3de3-4885-a633-5b92003f6fe4	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203068 application number: ANDA203068 ndc (product): 13107-061
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	DIRECT RX	c3dda0a4-b428-f3e7-e053-2995a90ad106	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203068 application number: ANDA203068 ndc (product): 72189-203
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Proficient Rx LP	b3c48b3c-fab7-4ea4-93b0-b108979e9da3	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203068 application number: ANDA203068 ndc (product): 63187-800

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13107-061	Phentermine Hydrochloride	Phentermine Hydrochloride	Aurolife Pharma, LLC	ANDA	Current
45865-556	Phentermine Hydrochloride	Phentermine Hydrochloride	medsource pharmaceuticals	ANDA	Current
50090-4216	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4216	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4216	Phentermine Hydrochloride	Phentermine Hydrochloride	A-S Medication Solutions	ANDA	Current
52959-812	Phentermine Hydrochloride	Phentermine Hydrochloride	H.J. Harkins Company, Inc.	ANDA	Current
63187-800	Phentermine Hydrochloride	Phentermine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-800	Phentermine Hydrochloride	Phentermine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-800	Phentermine Hydrochloride	Phentermine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-800	Phentermine Hydrochloride	Phentermine Hydrochloride	Proficient Rx LP	ANDA	Current
63187-800	Phentermine Hydrochloride	Phentermine Hydrochloride	Proficient Rx LP	ANDA	Current
70518-2278	Phentermine Hydrochloride	Phentermine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2278	Phentermine Hydrochloride	Phentermine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2278	Phentermine Hydrochloride	Phentermine Hydrochloride	REMEDYREPACK INC.	ANDA	Current
72189-203	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	DIRECT RX	ANDA	Current