Application 202088

Type: NDA
Sponsor: CITIUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUPRENZA	PHENTERMINE HYDROCHLORIDE	TABLET, ORALLY DISINTEGRATING;ORAL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	SUPRENZA	PHENTERMINE HYDROCHLORIDE	TABLET, ORALLY DISINTEGRATING;ORAL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
003	SUPRENZA	PHENTERMINE HYDROCHLORIDE	TABLET, ORALLY DISINTEGRATING;ORAL	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
N202088-001	SUPRENZA	PHENTERMINE HYDROCHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13
N202088-002	SUPRENZA	PHENTERMINE HYDROCHLORIDE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13
N202088-003	SUPRENZA	PHENTERMINE HYDROCHLORIDE	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2012-03-27

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N202088-001	8440170	2029-03-14	Drug product	2013-06-03
N202088-002	8440170	2029-03-14	Drug product
N202088-003	8440170	2029-03-14	Drug product

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202088-001	SUPRENZA	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202088-002	SUPRENZA	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202088-003	SUPRENZA	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2012-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202088-001	SUPRENZA	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202088-002	SUPRENZA	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202088-003	SUPRENZA	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2012-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202088-001	SUPRENZA	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202088-002	SUPRENZA	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202088-003	SUPRENZA	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2012-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202088-001	SUPRENZA	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202088-002	SUPRENZA	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202088-003	SUPRENZA	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2012-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202088-001	SUPRENZA	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202088-002	SUPRENZA	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202088-003	SUPRENZA	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2012-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202088-001	SUPRENZA	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202088-002	SUPRENZA	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202088-003	SUPRENZA	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2012-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202088-001	SUPRENZA	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202088-002	SUPRENZA	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202088-003	SUPRENZA	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2012-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202088-001	SUPRENZA	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202088-002	SUPRENZA	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202088-003	SUPRENZA	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2012-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202088-001	SUPRENZA	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202088-002	SUPRENZA	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202088-003	SUPRENZA	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2012-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202088-001	SUPRENZA	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202088-002	SUPRENZA	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202088-003	SUPRENZA	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2012-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202088-001	SUPRENZA	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202088-002	SUPRENZA	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202088-003	SUPRENZA	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2012-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202088-001	SUPRENZA	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202088-002	SUPRENZA	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202088-003	SUPRENZA	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2012-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202088-001	SUPRENZA	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202088-002	SUPRENZA	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202088-003	SUPRENZA	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2012-03-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202088-001	SUPRENZA	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	2011-06-13	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202088-001	8440170	2029-03-14	Drug product	2013-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202088-002	8440170	2029-03-14	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202088-003	8440170	2029-03-14	Drug product		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202088-001	8440170	2029-03-14	Drug product	2013-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202088-002	8440170	2029-03-14	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202088-003	8440170	2029-03-14	Drug product		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202088-001	8440170	2029-03-14	Drug product	2013-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202088-002	8440170	2029-03-14	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202088-003	8440170	2029-03-14	Drug product		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202088-001	8440170	2029-03-14	Drug product	2013-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202088-002	8440170	2029-03-14	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202088-003	8440170	2029-03-14	Drug product		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202088-001	8440170	2029-03-14	Drug product	2013-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202088-002	8440170	2029-03-14	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202088-003	8440170	2029-03-14	Drug product		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202088-001	8440170	2029-03-14	Drug product	2013-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202088-002	8440170	2029-03-14	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202088-003	8440170	2029-03-14	Drug product		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202088-001	8440170	2029-03-14	Drug product	2013-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202088-002	8440170	2029-03-14	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202088-003	8440170	2029-03-14	Drug product		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202088-001	8440170	2029-03-14	Drug product	2013-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202088-002	8440170	2029-03-14	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202088-003	8440170	2029-03-14	Drug product		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202088-001	8440170	2029-03-14	Drug product	2013-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202088-002	8440170	2029-03-14	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202088-003	8440170	2029-03-14	Drug product		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202088-001	8440170	2029-03-14	Drug product	2013-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202088-002	8440170	2029-03-14	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202088-003	8440170	2029-03-14	Drug product		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202088-001	8440170	2029-03-14	Drug product	2013-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202088-002	8440170	2029-03-14	Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202088-003	8440170	2029-03-14	Drug product		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202088-001	8440170	2029-03-14	Drug product	2013-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202088-002	8440170	2029-03-14	Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202088-003	8440170	2029-03-14	Drug product		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202088-001	8440170	2029-03-14	Drug product	2013-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202088-002	8440170	2029-03-14	Drug product		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202088-003	8440170	2029-03-14	Drug product		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202088-001	8440170	2029-03-14	Drug product	2013-06-03	`8072bd15b7f6…`

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 6 · 110 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Northwind Health Company, LLC	5528d9f7-45ad-d323-e063-6394a90a3e09	2026-06-25	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	Aurolife Pharma LLC	5927e0f6-3de3-4885-a633-5b92003f6fe4	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	19f1ce79-65f4-4bf4-a9ff-6ca0a131530f	2026-06-02	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	130e6087-0ab6-4456-a781-d370f363dc38	2026-06-01	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
LOMAIRA	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	0718f0f3-77f2-45d7-be12-1ed718c8b806	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	d24aaa53-9c78-4c1b-9495-c785a9cf2b26	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	2f3b738f-d66b-40c1-8e69-bcd50bce3e47	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	27e88ebe-6247-4598-8ef2-c882992ed579	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	3d1d4dde-1c7f-4a20-b8f8-897b1b284f80	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	d95e14f7-a46d-47fa-8dab-ee3d8d4c7b6d	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e6939fcf-3db2-492a-99ed-a384cdeea7a2	2026-05-11	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	eae1d7f9-733c-434b-9199-5f7052e541da	2026-04-14	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	328d6a39-34f4-4b74-a1bf-6ec6005b1322	2026-04-01	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	b425840f-380e-42bd-852a-6ee3641977ce	2026-03-23	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e48feec6-50c9-4ccd-b9da-56956d14c853	2026-03-18	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	9155edf8-ea1d-458f-b2a7-e0303fd83cc0	2026-03-16	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	c53bd3c5-01f6-4a21-9e3c-aa4969a01b4b	2026-03-04	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	aa9d7161-cda3-4ded-8d5b-424abd1a6681	2026-02-05	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	fa5de92d-a5bf-4ae1-8e13-ad827aeebea3	2026-02-04	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	86ec6b9d-2934-4bad-8a80-0b60e2f912f3	2026-01-24	Warnings, Adverse reactions	Name fallback generic name: PHENTERMINE HYDROCHLORIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
40113	SUPPL	2013-11-20
9953	SUPPL	2013-10-17
19055	SUPPL	2013-06-18
9952	SUPPL	2013-06-12
24405	ORIG	2013-05-24
22870	ORIG	2013-05-24
9951	SUPPL	2012-12-11
40112	SUPPL	2012-12-07
32172	SUPPL	2012-03-30
32171	ORIG	2012-03-29
40111	ORIG	2012-03-28
44842	ORIG	2012-03-09
22869	ORIG	2012-03-09
19054	SUPPL	2011-10-20
9950	SUPPL	2011-10-17
32170	ORIG	2011-06-16
19053	ORIG	2011-06-16