Application 016418

Type: NDA
Sponsor: WYETH PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INDERAL	PROPRANOLOL HYDROCHLORIDE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	INDERAL	PROPRANOLOL HYDROCHLORIDE	TABLET;ORAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	INDERAL	PROPRANOLOL HYDROCHLORIDE	TABLET;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	INDERAL	PROPRANOLOL HYDROCHLORIDE	TABLET;ORAL	80MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
009	INDERAL	PROPRANOLOL HYDROCHLORIDE	TABLET;ORAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
010	INDERAL	PROPRANOLOL HYDROCHLORIDE	TABLET;ORAL	90MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N016418-001	INDERAL	PROPRANOLOL HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N016418-002	INDERAL	PROPRANOLOL HYDROCHLORIDE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N016418-003	INDERAL	PROPRANOLOL HYDROCHLORIDE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N016418-004	INDERAL	PROPRANOLOL HYDROCHLORIDE	80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N016418-009	INDERAL	PROPRANOLOL HYDROCHLORIDE	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-10-18
N016418-010	INDERAL	PROPRANOLOL HYDROCHLORIDE	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-10-18

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 4 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N016418-001	INDERAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016418-002	INDERAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016418-003	INDERAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016418-004	INDERAL	80MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016418-009	INDERAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016418-010	INDERAL	90MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016418-001	INDERAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016418-002	INDERAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016418-003	INDERAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016418-004	INDERAL	80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016418-009	INDERAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-10-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016418-010	INDERAL	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1982-10-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016418-001	INDERAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016418-002	INDERAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016418-003	INDERAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016418-004	INDERAL	80MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016418-009	INDERAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-10-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N016418-010	INDERAL	90MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-10-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016418-001	INDERAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016418-002	INDERAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016418-003	INDERAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016418-004	INDERAL	80MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016418-009	INDERAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-10-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016418-010	INDERAL	90MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-10-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016418-001	INDERAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016418-002	INDERAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016418-003	INDERAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016418-004	INDERAL	80MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016418-009	INDERAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-10-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N016418-010	INDERAL	90MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-10-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016418-001	INDERAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016418-002	INDERAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016418-003	INDERAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016418-004	INDERAL	80MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016418-009	INDERAL	60MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-10-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N016418-010	INDERAL	90MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1982-10-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016418-001	INDERAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016418-002	INDERAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016418-003	INDERAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N016418-004	INDERAL	80MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982		`c0c555d07b60…`

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 7 · 135 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Golden State Medical Supply, Inc.	5affa0ea-db84-86fd-e063-6294a90a4d16	2026-09-08	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	f7ae2dac-6048-41ea-95d3-cad06cc2baf3	2026-09-03	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	American Health Packaging	c751ee54-27b4-4ed7-829a-ced735c41312	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	American Health Packaging	d027f39e-7648-44c8-a8dc-b26b4cdd81be	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Inderal XL	PROPRANOLOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	ac196ff5-9215-402b-bc57-69aa87f8bade	2026-08-27	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
InnoPran XL	PROPRANOLOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	cd5601b3-4d87-4c3b-acac-b476e787609d	2026-08-27	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride ER	PROPRANOLOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	5415904b-90da-48e8-9f9e-f86749aa129c	2026-08-27	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Par Health USA, LLC	0d74bb04-8227-4afa-b523-ce1556150e07	2026-08-26	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	52da1afc-7f1c-4893-ab84-8479dd939951	2026-08-24	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	1791ef4d-b609-41c8-b4ef-15bff752ddd7	2026-08-24	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	d9759182-e681-4c7e-af36-9f7b2184df3c	2026-08-24	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
INDERAL LA	PROPRANOLOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	35d28979-36b1-4630-b85e-a44e0a443734	2026-08-24	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Creekwood Pharmaceuticals LLC	289f39f4-ebd3-4fd9-bbb3-72de8124795a	2026-08-21	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	a3bd3ef9-539d-450e-900b-95be0e46095b	2026-08-10	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	fa5b6189-3419-4134-8bfe-c0d0c77df828	2026-08-10	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	e3f615e0-07da-491c-9620-7083f4f4318a	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	1cd914b6-b250-4b11-8404-41db3589361e	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	07c3fcab-33fe-4a6a-ba67-2d042190c146	2026-08-04	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	49d09308-74b0-4f9a-9c03-37234b5ee3a3	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Cardinal Health 107, LLC	1df7f35e-b1d8-4aca-875e-d197cb61239e	2026-07-29	Warnings, Adverse reactions	Name fallback generic name: PROPRANOLOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
12996	SUPPL	2011-03-23
10890	SUPPL	2011-03-22
12995	SUPPL	2008-05-09
12994	SUPPL	2007-09-07
10889	SUPPL	2007-09-07
12993	SUPPL	2007-03-06
444	SUPPL	2007-01-08
33165	SUPPL	2004-08-25
443	SUPPL	2004-08-25