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.

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
2019-12-13 00:20 UTC	2019-12	A201209-001	BENZONATATE	150MG	CAPSULE / ORAL	AA	RS	2014-09-24	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A201209-001	BENZONATATE	150MG	CAPSULE / ORAL	AA	RS	2014-09-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201209-001	BENZONATATE	150MG	CAPSULE / ORAL	AA	RS	2014-09-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201209-001	BENZONATATE	150MG	CAPSULE / ORAL	AA	RS	2014-09-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201209-001	BENZONATATE	150MG	CAPSULE / ORAL	AA	RS	2014-09-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201209-001	BENZONATATE	150MG	CAPSULE / ORAL	AA	RS	2014-09-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201209-001	BENZONATATE	150MG	CAPSULE / ORAL	AA	RS	2014-09-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201209-001	BENZONATATE	150MG	CAPSULE / ORAL	AA	RS	2014-09-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201209-001	BENZONATATE	150MG	CAPSULE / ORAL	AA	RS	2014-09-24	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A201209-001	AA	1	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	A201209-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201209-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201209-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201209-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201209-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201209-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201209-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201209-001	AA	1	`ea99ee380514…`

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 6 of 6 · 106 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	Proficient Rx LP	19f1e761-69e9-4330-ad3c-1f1180d70cb0	2021-01-01	Boxed warning, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
benzonatate	BENZONATATE	Proficient Rx LP	9fb78c06-e527-4596-884c-fcf882927a33	2020-02-01	Warnings, Adverse reactions	Name fallback brand name: benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Proficient Rx LP	0d14cbf4-f43f-4ad2-8e8b-7a844e417702	2020-01-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
benzonatate	BENZONATATE	Proficient Rx LP	27156dad-64d6-4ea4-a3da-29e8e096fb01	2020-01-01	Warnings, Adverse reactions	Name fallback brand name: benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Proficient Rx LP	a7b12862-1c9f-4712-93e6-a859b24728c2	2019-11-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
benzonatate	BENZONATATE	Bryant Ranch Prepack	143a5ba8-0ee9-43be-a0da-2c455c1a46bd	2019-09-11	Warnings, Adverse reactions	Name fallback brand name: benzonatate generic name: BENZONATATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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