Application 070213

Type
ANDA
Sponsor
MYLAN

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A070213-001PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-19
A070213-002PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-19
A070213-003PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-19
A070213-004PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-19
A070213-005PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070213-001AB
A070213-002AB
A070213-003AB
A070213-004AB
A070213-005AB

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 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A070213-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-19caaa826d4ba7…
2026-08-18 06:07:402026-07A070213-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-19caaa826d4ba7…
2026-08-18 06:07:402026-07A070213-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-19caaa826d4ba7…
2026-08-18 06:07:402026-07A070213-004PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-19caaa826d4ba7…
2026-08-18 06:07:402026-07A070213-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070213-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070213-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070213-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070213-004PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070213-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-004PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A070213-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070213-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070213-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070213-004PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070213-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-004PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-004PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-004PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-001PROPRANOLOL HYDROCHLORIDE40MGTABLET / ORALAB1985-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-002PROPRANOLOL HYDROCHLORIDE10MGTABLET / ORALAB1985-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-003PROPRANOLOL HYDROCHLORIDE20MGTABLET / ORALAB1985-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-004PROPRANOLOL HYDROCHLORIDE80MGTABLET / ORALAB1985-11-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-005PROPRANOLOL HYDROCHLORIDE60MGTABLET / ORALAB2011-04-082680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A070213-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070213-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070213-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070213-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A070213-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A070213-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070213-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070213-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070213-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A070213-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070213-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070213-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070213-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070213-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070213-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A070213-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070213-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070213-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070213-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070213-005AB12680178bc6a6…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEGolden State Medical Supply, Inc.8cbac6dc-ef1d-6662-e053-2995a90af13f2026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070213
application number: ANDA070213
ndc (product): 51407-237
ndc (product): 51407-239
ndc (product): 51407-236
ndc (product): 51407-235
ndc (product): 51407-238
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC7da9bb37-cc22-4eff-8de0-429f64cb599e2026-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070213
application number: ANDA070213
ndc (product): 43353-084
ndc (product): 43353-961
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEMylan Pharmaceuticals Inc.b94dcec7-7633-4a33-9cea-48161adeaf932026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070213
application number: ANDA070213
ndc (product): 0378-0187
ndc (product): 0378-0184
ndc (product): 0378-0182
ndc (product): 0378-0185
ndc (product): 0378-0183
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3c05ab1f-05b0-494a-b640-667e7cf517a12021-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070213
application number: ANDA070213
ndc (product): 71610-339

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0182Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0182Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0182Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0183Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0183Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0183Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0184Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0184Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0184Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0185Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0185Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0185Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0187Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0187Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-0187Propranolol Hydrochloridepropranolol hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0615-2561Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2562Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-2563Propranolol HydrochloridePropranolol HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43353-084Propranolol Hydrochloridepropranolol hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-961Propranolol Hydrochloridepropranolol hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
51407-235Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply Inc.ANDACurrent
51407-235Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-235Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-235Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-236Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply Inc.ANDACurrent
51407-236Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-236Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-236Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-237Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply Inc.ANDACurrent
51407-237Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-237Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-237Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-238Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply Inc.ANDACurrent
51407-238Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-238Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-238Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-239Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply Inc.ANDACurrent
51407-239Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-239Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-239Propranolol Hydrochloridepropranolol hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51655-318Propranolol HyrochloridePropranolol HydrochlorideNorthwind PharmaceuticalsANDACurrent
70518-1286Propranolol Hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1286Propranolol Hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1963Propranolol Hydrochloridepropranolol hydrochlorideREMEDYREPACK INC.ANDACurrent
71610-339Propranolol Hydrochloridepropranolol hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-339Propranolol Hydrochloridepropranolol hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent