Application 203495

Type: ANDA
Sponsor: AVANTHI INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOMAIRA	PHENTERMINE HYDROCHLORIDE	TABLET;ORAL	8MG	No	Yes

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
A203495-001	LOMAIRA	PHENTERMINE HYDROCHLORIDE	8MG	TABLET / ORAL	AA	RS	2016-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203495-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A203495-001	AA	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LOMAIRA	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	0718f0f3-77f2-45d7-be12-1ed718c8b806	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203495 application number: ANDA203495
LOMAIRA	PHENTERMINE HYDROCHLORIDE	KVK-TECH, INC.	cde9fb09-e5af-434d-8874-e4f9f974d893	2023-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203495 application number: ANDA203495 ndc (product): 10702-001

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10702-001	LOMAIRA	Phentermine Hydrochloride	KVK-TECH, INC.	ANDA	Current
63629-7874	LOMAIRA	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-7874	LOMAIRA	Phentermine Hydrochloride	Bryant Ranch Prepack	ANDA	Current