Application 070322

Type
ANDA
Sponsor
INNOGENIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDETABLET;ORAL80MGNoNo
002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDETABLET;ORAL10MGNoNo
003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDETABLET;ORAL20MGNoNo
004PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDETABLET;ORAL40MGNoNo
005PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDETABLET;ORAL60MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A070322-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-04
A070322-002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-22
A070322-003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-22
A070322-004PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-22
A070322-005PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A070322-001AB
A070322-002AB
A070322-003AB
A070322-004AB
A070322-005AB

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 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-0484e616aacf4f…
2026-09-14 22:38:342026-08A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-2284e616aacf4f…
2026-09-14 22:38:342026-08A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-2284e616aacf4f…
2026-09-14 22:38:342026-08A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-2284e616aacf4f…
2026-09-14 22:38:342026-08A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-2484e616aacf4f…
2026-08-18 06:07:402026-07A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-04caaa826d4ba7…
2026-08-18 06:07:402026-07A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-22caaa826d4ba7…
2026-08-18 06:07:402026-07A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-001PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1986-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-004PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB1986-09-2403ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A070322-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A070322-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A070322-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A070322-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A070322-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A070322-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070322-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070322-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070322-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070322-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070322-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070322-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070322-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070322-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070322-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070322-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070322-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070322-005AB103ed91905a0d…

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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAMICI PHARMACEUTICALS LLC8efc9fc6-6db0-43c9-892b-7423a9ba679f2023-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
ndc (product): 69292-538
ndc (product): 69292-530
ndc (product): 69292-532
ndc (product): 69292-536
ndc (product): 69292-534
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LPec9e45ed-4c62-4075-b40e-2a9e40ac682b2022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
ndc (product): 71205-590
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEProficient Rx LPea86beb4-33c8-4841-a742-82212ce716d22022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070322
application number: ANDA070322
ndc (product): 71205-446

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 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51655-426Propranolol HydrochloridePropranolol HydrochlorideNorthwind PharmaceuticalsANDACurrent
60687-587Propranolol HydrochloridePropranolol HydrochlorideAmerican Health PackagingANDACurrent
60687-587Propranolol HydrochloridePropranolol HydrochlorideAmerican Health PackagingANDACurrent
60687-598Propranolol HydrochloridePropranolol HydrochlorideAmerican Health PackagingANDACurrent
60687-598Propranolol HydrochloridePropranolol HydrochlorideAmerican Health PackagingANDACurrent
60687-609Propranolol HydrochloridePropranolol HydrochlorideAmerican Health PackagingANDACurrent
60687-609Propranolol HydrochloridePropranolol HydrochlorideAmerican Health PackagingANDACurrent
60760-545Propranolol HydrochloridePropranolol HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
68071-2424Propranolol hydrochloridePropranolol hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2484Propranolol HydrochloridePropranolol HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2710Propranolol HydrochloridePropranolol HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7791Propranolol HydrochloridePropranolol HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7791Propranolol HydrochloridePropranolol HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7791Propranolol HydrochloridePropranolol HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7860Propranolol HydrochloridePropranolol HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7860Propranolol HydrochloridePropranolol HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
69292-530Propranolol HydrochloridePropranolol HydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
69292-530Propranolol HydrochloridePropranolol HydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
69292-530Propranolol HydrochloridePropranolol HydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
69292-532Propranolol HydrochloridePropranolol HydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
69292-532Propranolol HydrochloridePropranolol HydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
69292-532Propranolol HydrochloridePropranolol HydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
69292-534Propranolol HydrochloridePropranolol HydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
69292-534Propranolol HydrochloridePropranolol HydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
69292-534Propranolol HydrochloridePropranolol HydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
69292-536Propranolol HydrochloridePropranolol HydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
69292-536Propranolol HydrochloridePropranolol HydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
69292-536Propranolol HydrochloridePropranolol HydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
69292-538Propranolol hydrochloridePropranolol hydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
69292-538Propranolol hydrochloridePropranolol hydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
69292-538Propranolol hydrochloridePropranolol hydrochlorideAMICI PHARMACEUTICALS LLCANDACurrent
70518-3053Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3102Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3102Propranolol HydrochloridePropranolol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3141Propranolol hydrochloridePropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70934-581Propranolol HydrochloridePropranolol HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-922Propranolol HydrochloridePropranolol HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-922Propranolol HydrochloridePropranolol HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-446Propranolol HydrochloridePropranolol HydrochlorideProficient Rx LPANDACurrent
71205-446Propranolol HydrochloridePropranolol HydrochlorideProficient Rx LPANDACurrent
71205-590Propranolol HydrochloridePropranolol HydrochlorideProficient Rx LPANDACurrent
71205-590Propranolol HydrochloridePropranolol HydrochlorideProficient Rx LPANDACurrent
71335-1712Propranolol HydrochloridePropranolol HydrochlorideBryant Ranch PrepackANDACurrent
71335-1712Propranolol HydrochloridePropranolol HydrochlorideBryant Ranch PrepackANDACurrent
71335-1712Propranolol HydrochloridePropranolol HydrochlorideBryant Ranch PrepackANDACurrent
71335-1994Propranolol HydrochloridePropranolol HydrochlorideBryant Ranch PrepackANDACurrent
72189-322PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEDirect RxANDACurrent
72189-322PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEDirect RxANDACurrent
72189-322PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEDirect RxANDACurrent
72189-322PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEDirect RxANDACurrent