FDA.reportPublic FDA data

Application 070219

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDETABLET;ORAL40MGNoNo

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 UTC2019-12A070219-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-08-0174a2ff9319b5…
2021-12-28 21:50 UTC2021-12A070219-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-08-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070219-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-08-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A070219-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-08-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070219-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-08-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070219-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-08-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070219-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-08-013f01610625f2…
2019-09-15 20:21 UTC2019-09A070219-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-08-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A070219-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1986-08-01ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A070219-001AB174a2ff9319b5…
2021-12-28 21:50 UTC2021-12A070219-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070219-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A070219-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070219-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070219-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070219-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070219-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070219-001AB1ea99ee380514…

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
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.29a3a271-dabc-437f-e054-00144ff8d46c2025-02-28Warnings, Adverse reactionsExact identifier
ndc (product): 43063-647
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepack360de855-b8be-409f-9ca6-d0a0368af1742024-12-09Warnings, Adverse reactionsExact identifier
ndc (product): 71335-0472
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackb27ade81-8b41-4394-aec1-d23370bfa3b72024-10-10Warnings, Adverse reactionsExact identifier
ndc (product): 63629-2279
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEBryant Ranch Prepackd655fb2d-0cfd-4aad-8770-5decdcee10b22024-10-09Warnings, Adverse reactionsExact identifier
ndc (product): 63629-2278
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEEndo USA, Inc.0d74bb04-8227-4afa-b523-ce1556150e072024-09-24Warnings, Adverse reactionsExact identifier
ndc (product): 0603-5484

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-5484Propranolol Hydrochloridepropranolol hydrochloridePar PharmaceuticalANDACurrent
0603-5484Propranolol Hydrochloridepropranolol hydrochloridePar Pharmaceutical, Inc.ANDACurrent
0603-5484Propranolol Hydrochloridepropranolol hydrochloridePar PharmaceuticalANDACurrent
43063-647Propranolol Hydrochloridepropranolol hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-647Propranolol Hydrochloridepropranolol hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-647Propranolol Hydrochloridepropranolol hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-647Propranolol Hydrochloridepropranolol hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-647Propranolol Hydrochloridepropranolol hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-647Propranolol Hydrochloridepropranolol hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-647Propranolol Hydrochloridepropranolol hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-706Propranolol Hydrochloridepropranolol hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-0149Propranolol Hydrochloridepropranolol hydrochlorideA-S Medication SolutionsANDACurrent
50090-0149Propranolol Hydrochloridepropranolol hydrochlorideA-S Medication SolutionsANDACurrent
50090-0149Propranolol Hydrochloridepropranolol hydrochlorideA-S Medication SolutionsANDACurrent
53217-378Propranolol Hydrochloridepropranolol hydrochlorideAidarex Pharmaceuticals LLCANDACurrent
63629-2278Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent
63629-2279Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent
66267-181Propranolol Hydrochloridepropranolol hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-181Propranolol Hydrochloridepropranolol hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
67296-1273Propranolol HydrochloridePropranolol HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1273Propranolol HydrochloridePropranolol HydrochlorideRedPharm Drug, Inc.ANDACurrent
68071-1856Propranolol Hydrochloridepropranolol hydrochlorideNuCare Pharmceuticals,Inc.ANDACurrent
68071-4794Propranolol Hydrochloridepropranolol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4794Propranolol Hydrochloridepropranolol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-2429Propranolol Hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2429Propranolol Hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2429Propranolol Hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0472Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent
71335-0472Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent
71335-0472Propranolol Hydrochloridepropranolol hydrochlorideBryant Ranch PrepackANDACurrent