Application 201209

Type: ANDA
Sponsor: THEPHARMANETWORK LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BENZONATATE	BENZONATATE	CAPSULE;ORAL	150MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog.

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 6 · 110 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	REMEDYREPACK INC.	23a5de40-76d0-4117-8d31-2b2f8a6b0a28	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	REMEDYREPACK INC.	ed756746-4cbb-4196-a972-5a8c23702b2a	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Sportpharm LLC	df48d617-a3c2-4776-937d-ccfca651d4fc	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	St. Mary's Medical Park Pharmacy	3f686042-02bc-8a78-e063-6294a90a7f56	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	5728b147-33a0-4534-b936-3e02274d9467	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Golden State Medical Supply, Inc.	d580b1c9-d450-4032-acb2-0563c589ed2c	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	A-S Medication Solutions	e6f5f2c2-1c59-405c-97bf-ee73740869d2	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	A-S Medication Solutions	434130e1-c29c-4029-92c6-7d0f7a928e68	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Major Pharmaceuticals	324f65ae-09d1-4bd6-9d2b-593035201ecd	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	da093b5e-83a7-467e-9716-bc5827a18c20	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	865a6317-c697-4dbe-9074-4a955036cdd7	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	0f91fd98-1a86-42aa-8055-d339bff73015	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bionpharma Inc.	2630be01-1d2d-4c40-8e56-8568ea89eacf	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
BENZONATATE	BENZONATATE	Strides Pharma Science Limited	89f5d18e-5ef4-42a3-bc6f-abf4f308462b	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: BENZONATATE generic name: BENZONATATE
Benzonatate	BENZONATATE	St. Mary's Medical Park Pharmacy	96250e05-4608-7d5c-e053-2995a90ad57a	2026-06-02	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
benzonatate	BENZONATATE	Bryant Ranch Prepack	a788cb01-6dc3-4f28-aaa0-c23ac058c39a	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	540d2bc6-11dc-43d7-b616-b89d75b81cd1	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Anvi Pharmaceuticals Inc	7c733168-355e-4753-8d52-59a06fb39952	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Redpharm drug, inc	f3c23663-0cb7-ffa4-e053-2a95a90a9ae0	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Camber Pharmaceuticals, Inc.	c21afd18-3b04-4f15-874b-25e0c768f801	2026-05-11	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-5187	benzonatate	benzonatate	Liberty Pharmaceuticals, Inc.	ANDA	Current
67877-128	benzonatate	benzonatate	Ascend Laboratories LLC	ANDA	Current
67877-128	benzonatate	benzonatate	Ascend Laboratories LLC	ANDA	Current
67877-574	benzonatate	benzonatate	Ascend Laboratories LLC	ANDA	Current