FDA.reportPublic FDA data

Application 075141

Type
ANDA
Sponsor
GALT PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORPHENGESICASPIRIN; CAFFEINE; ORPHENADRINE CITRATETABLET;ORAL385MG;30MG;25MGNoNo
002ORPHENGESIC FORTEASPIRIN; CAFFEINE; ORPHENADRINE CITRATETABLET;ORAL770MG;60MG;50MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075141-001ORPHENGESICASPIRIN; CAFFEINE; ORPHENADRINE CITRATE385MG;30MG;25MGTABLET / ORAL1998-05-29
A075141-002ORPHENGESIC FORTEASPIRIN; CAFFEINE; ORPHENADRINE CITRATE770MG;60MG;50MGTABLET / ORALRS1998-05-29

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALAB1998-05-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALRS1998-05-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALRS1998-05-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-2987673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALRS1998-05-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-295aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALRS1998-05-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-298869cabd3fbd…
2020-12-22 03:56 UTC2020-12A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALRS1998-05-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-29c0c555d07b60…
2020-11-12 02:37 UTC2020-11A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALRS1998-05-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-293f01610625f2…
2019-12-14 00:12 UTC2019-12A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALAB1998-05-293f01610625f2…
2019-09-15 20:21 UTC2019-09A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-29b00525d2431f…
2019-09-15 20:21 UTC2019-09A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALAB1998-05-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-29ea99ee380514…
2019-07-19 19:46 UTC2019-07A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALAB1998-05-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-296a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALRS1998-05-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-291c564ffb4f44…
2024-02-18 07:12 UTC2024-02A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALRS1998-05-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-29ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALRS1998-05-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-29a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALRS1998-05-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-299b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALRS1998-05-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-29a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALRS1998-05-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-293f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALRS1998-05-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-29053a50430f4f…
2023-05-13 08:27 UTC2023-05A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALRS1998-05-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-293bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALRS1998-05-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075141-001ORPHENGESIC385MG;30MG;25MGTABLET / ORAL1998-05-293a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075141-002ORPHENGESIC FORTE770MG;60MG;50MGTABLET / ORALRS1998-05-293a93d1ddd44b…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A075141-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A075141-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075141-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075141-002AB1ea99ee380514…

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
NorgesicORPHENADRINE CITRATE, ASPIRIN AND CAFFEINEGalt Pharmaceuticals, LLCbe2761bc-e537-4039-846a-2ffa3d8b2afc2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075141
application number: ANDA075141
ndc (product): 61825-305
Norgesic ForteORPHENADRINE CITRATE, ASPIRIN AND CAFFEINEPoly Pharmaceuticals, Inc.85a3b808-b476-f2f0-e053-2a91aa0af21f2025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075141
application number: ANDA075141
ndc (product): 50991-999
Orphenadrine Citrate, Aspirin and CaffeineORPHENADRINE CITRATE, ASPIRIN AND CAFFEINEAtland Pharmaceuticals, LLC7776aae6-3cbd-4aed-9aac-4bed80339e272025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075141
application number: ANDA075141
ORPHENGESIC FORTEORPHENADRINE CITRATE, ASPIRIN AND CAFFEINEGalt Pharmaceuticals, LLC5bc485db-9d96-4291-aaa3-2a96ebf3098a2025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075141
application number: ANDA075141
ndc (product): 61825-302
Orphenadrine Citrate, Aspirin and CaffeineORPHENADRINE CITRATE, ASPIRIN AND CAFFEINEAtland Pharmaceuticals, LLC61ca2af1-081c-411c-90ce-ec6d9e3157b22025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075141
application number: ANDA075141
ndc (product): 71993-304

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50991-999Norgesic ForteOrphenadrine Citrate, Aspirin and CaffeinePoly Pharmaceuticals, Inc.ANDACurrent
50991-999Norgesic ForteOrphenadrine Citrate, Aspirin and CaffeinePoly Pharmaceuticals, Inc.ANDACurrent
50991-999Norgesic ForteOrphenadrine Citrate, Aspirin and CaffeinePoly Pharmaceuticals, Inc.ANDACurrent
50991-999Norgesic ForteOrphenadrine Citrate, Aspirin and CaffeinePoly Pharmaceuticals, Inc.ANDACurrent
61825-302ORPHENGESIC FORTEOrphenadrine Citrate, Aspirin and CaffeineGalt Pharmaceuticals, LLCANDACurrent
61825-302ORPHENGESIC FORTEOrphenadrine Citrate, Aspirin and CaffeineGalt Pharmaceuticals, LLCANDACurrent
61825-302ORPHENGESIC FORTEOrphenadrine Citrate, Aspirin and CaffeineGalt Pharmaceuticals, LLCANDACurrent
61825-305NorgesicOrphenadrine Citrate, Aspirin and CaffeineGalt Pharmaceuticals, LLCANDACurrent
61825-999Orphengesic ForteOrphenadrine Citrate, Aspirin and CaffeineGalt Pharmaceuticals, LLCANDACurrent
61825-999Orphengesic ForteOrphenadrine Citrate, Aspirin and CaffeineGalt Pharmaceuticals, LLCANDACurrent
71993-304Orphenadrine Citrate, Aspirin and CaffeineOrphenadrine Citrate, Aspirin and CaffeineAtland Pharmaceuticals, LLCANDACurrent
71993-304Orphenadrine Citrate, Aspirin and CaffeineOrphenadrine Citrate, Aspirin and CaffeineAtland Pharmaceuticals, LLCANDACurrent
71993-999Orphenadrine Citrate, Aspirin and CaffeineOrphenadrine Citrate, Aspirin and CaffeineAtland Pharmaceuticals, LLCANDACurrent
71993-999Orphenadrine Citrate, Aspirin and CaffeineOrphenadrine Citrate, Aspirin and CaffeineAtland Pharmaceuticals, LLCANDACurrent
74157-999Orphenadrine Citrate, Aspirin and Caffeineorphenadrine citrate, aspirin and caffeineINA Pharmaceutics, IncANDACurrent
74157-999Orphenadrine Citrate, Aspirin and Caffeineorphenadrine citrate, aspirin and caffeineINA Pharmaceutics, IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22431ORIG1998-05-29