FDA.reportPublic FDA data

Application 040749

Type
ANDA
Sponsor
THEPHARMANETWORK LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZONATATEBENZONATATECAPSULE;ORAL200MGNoYes

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-2574a2ff9319b5…
2021-12-28 21:50 UTC2021-12A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-253f01610625f2…
2019-09-15 20:21 UTC2019-09A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A040749-001BENZONATATE200MGCAPSULE / ORALAARS2007-07-25ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A040749-001AA174a2ff9319b5…
2021-12-28 21:50 UTC2021-12A040749-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040749-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040749-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040749-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040749-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040749-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040749-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040749-001AA1ea99ee380514…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
benzonatateBENZONATATEBryant Ranch Prepacka788cb01-6dc3-4f28-aaa0-c23ac058c39a2026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040749
application number: ANDA040749
ndc (product): 71335-0725
BENZONATATEBENZONATATEQPharma, Inc.55c4ae18-3e37-4caf-9fdb-9d307970b5f92025-12-21Warnings, Adverse reactionsExact identifier
ndc (product): 42708-082
BENZONATATEBENZONATATEAscend Laboratories, LLC54374c04-63b9-49fa-b6a2-4a711e322d8e2025-12-02Warnings, Adverse reactionsExact identifier
ndc (product): 67877-575
benzonatateBENZONATATEProficient Rx LP9566b9b9-54ef-423c-8ce4-0f17140521582022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040749
application number: ANDA040749
ndc (product): 71205-972
benzonatateBENZONATATEProficient Rx LP27156dad-64d6-4ea4-a3da-29e8e096fb012020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040749
application number: ANDA040749
ndc (product): 71205-037

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 66 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-5186benzonatatebenzonatateLiberty Pharmaceuticals, Inc.ANDACurrent
0440-7186benzonatatebenzonatateLiberty Pharmaceuticals, Inc.ANDACurrent
0440-7186benzonatatebenzonatateLiberty Pharmaceuticals, Inc.ANDACurrent
0904-5905benzonatatebenzonatateMAJOR PHARMACEUTICALS INCANDACurrent
10544-094benzonatatebenzonatateBlenheim Pharmacal, Inc.ANDACurrent
10544-123benzonatatebenzonatateBlenheim Pharmacal, Inc.ANDACurrent
10544-129benzonatatebenzonatateBlenheim Pharmacal, Inc.ANDACurrent
21695-760benzonatatebenzonatateRebel Distributors CorpANDACurrent
33261-634benzonatatebenzonatateAidarex Pharmaceuticals LLCANDACurrent
42708-082benzonatatebenzonatateQPharma IncANDACurrent
42708-082benzonatatebenzonatateQPharma IncANDACurrent
42708-107benzonatatebenzonatateQPharma IncANDACurrent
42708-107benzonatatebenzonatateQPharma IncANDACurrent
42708-107benzonatatebenzonatateQPharma IncANDACurrent
43063-799benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-799benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-799benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-799benzonatatebenzonatatePD-Rx Pharmaceuticals, Inc.ANDACurrent
49999-552benzonatatebenzonatateLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-3246benzonatatebenzonatateA-S Medication SolutionsANDACurrent
50090-3246benzonatatebenzonatateA-S Medication SolutionsANDACurrent
50436-5996benzonatatebenzonatateUnit Dose ServicesANDACurrent
51655-770BenzonatateBenzonatateNorthwind Pharmaceuticals, LLCANDACurrent
52959-410benzonatatebenzonatateH.J. Harkins Company, Inc.ANDACurrent
53002-0410benzonatatebenzonatateRPK Pharmaceuticals, Inc.ANDACurrent
53002-0410benzonatatebenzonatateRPK Pharmaceuticals, Inc.ANDACurrent
53002-0412benzonatatebenzonatateRPK Pharmaceuticals, Inc.ANDACurrent
53217-338benzonatatebenzonatateAidarex Pharmaceuticals LLCANDACurrent
55700-561benzonatatebenzonatateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-561benzonatatebenzonatateLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-517BENZONATATEBENZONATATEDIRECT RXANDACurrent
61919-517BENZONATATEBENZONATATEDirect_RxANDACurrent
61919-517BENZONATATEBENZONATATEDirect_RxANDACurrent
63629-1052benzonatatebenzonatateBryant Ranch PrepackANDACurrent
63629-1053benzonatatebenzonatateBryant Ranch PrepackANDACurrent
63629-7647benzonatatebenzonatateBryant Ranch PrepackANDACurrent
63629-7647benzonatatebenzonatateBryant Ranch PrepackANDACurrent
63629-7949benzonatatebenzonatateBryant Ranch PrepackANDACurrent
63739-124benzonatatebenzonatateMcKesson CorporationANDACurrent
67296-0822benzonatatebenzonatateRedPharm Drug Inc.ANDACurrent
67296-1583benzonatatebenzonatateRedPharm Drug, Inc.ANDACurrent
67296-1583benzonatatebenzonatateRedPharm Drug, Inc.ANDACurrent
67877-106benzonatatebenzonatateAscend Laboratories LLCANDACurrent
67877-106benzonatatebenzonatateAscend Laboratories LLCANDACurrent
67877-575benzonatatebenzonatateAscend Laboratories LLCANDACurrent
68071-3185benzonatatebenzonatateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4258benzonatatebenzonatateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4258benzonatatebenzonatateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7087benzonatatebenzonatatePreferred Pharmaceuticals IncANDACurrent
68788-7087benzonatatebenzonatatePreferred Pharmaceuticals IncANDACurrent
68788-7087benzonatatebenzonatatePreferred Pharmaceuticals IncANDACurrent
68788-7087benzonatatebenzonatatePreferred Pharmaceuticals IncANDACurrent
68788-9502benzonatatebenzonatatePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0043benzonatatebenzonatateREMEDYREPACK INC.ANDACurrent
70518-1338benzonatatebenzonatateREMEDYREPACK INC.ANDACurrent
70518-1338benzonatatebenzonatateREMEDYREPACK INC.ANDACurrent
70934-078benzonatatebenzonatateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-078benzonatatebenzonatateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-078benzonatatebenzonatateDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-037benzonatatebenzonatateProficient Rx LPANDACurrent
71205-037benzonatatebenzonatateProficient Rx LPANDACurrent
71205-037benzonatatebenzonatateProficient Rx LPANDACurrent
71205-972benzonatatebenzonatateProficient Rx LPANDACurrent
71205-972benzonatatebenzonatateProficient Rx LPANDACurrent
71335-0725benzonatatebenzonatateBryant Ranch PrepackANDACurrent
71335-0725benzonatatebenzonatateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7678ORIG2007-07-30