Application 021438

Type: NDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INNOPRAN XL	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	80MG	Yes	No
002	INNOPRAN XL	PROPRANOLOL HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021438-001	INNOPRAN XL	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12
N021438-002	INNOPRAN XL	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021438-001	BX
N021438-002	BX

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021438-001	INNOPRAN XL	80MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD	2003-03-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021438-002	INNOPRAN XL	120MG	CAPSULE, EXTENDED RELEASE / ORAL	BX	RLD, RS	2003-03-12	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021438-001	BX	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021438-002	BX	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021438-001	BX	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021438-002	BX	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021438-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021438-002	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021438-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021438-002	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021438-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021438-002	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021438-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021438-002	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021438-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021438-002	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021438-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021438-002	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021438-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021438-002	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021438-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021438-002	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021438-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021438-002	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021438-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021438-002	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021438-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021438-002	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021438-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021438-002	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021438-001	BX	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021438-002	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021438-001	BX	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021438-002	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021438-001	BX	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021438-002	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021438-001	BX	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021438-002	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021438-001	BX	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021438-002	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021438-001	BX	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021438-002	BX	1	`74a2ff9319b5…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021438-001	6500454	2021-10-04	Drug product	2003-03-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021438-002	6500454	2021-10-04	Drug product		`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021438-001	6500454	2021-10-04	Drug product	2003-03-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021438-002	6500454	2021-10-04	Drug product		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021438-001	6500454	2021-10-04	Drug product	2003-03-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021438-002	6500454	2021-10-04	Drug product		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021438-001	6500454	2021-10-04	Drug product	2003-03-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021438-002	6500454	2021-10-04	Drug product		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021438-001	6500454	2021-10-04	Drug product	2003-03-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021438-002	6500454	2021-10-04	Drug product		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021438-001	6500454	2021-10-04	Drug product	2003-03-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021438-002	6500454	2021-10-04	Drug product		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021438-001	6500454	2021-10-04	Drug product	2003-03-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021438-002	6500454	2021-10-04	Drug product		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021438-001	6500454	2021-10-04	Drug product	2003-03-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021438-002	6500454	2021-10-04	Drug product		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021438-001	6500454	2021-10-04	Drug product	2003-03-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021438-002	6500454	2021-10-04	Drug product		`ea99ee380514…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Inderal XL	PROPRANOLOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	ac196ff5-9215-402b-bc57-69aa87f8bade	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021438 application number: NDA021438 ndc (product): 62559-600 ndc (product): 62559-601
InnoPran XL	PROPRANOLOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	cd5601b3-4d87-4c3b-acac-b476e787609d	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021438 application number: NDA021438 ndc (product): 62559-590 ndc (product): 62559-591

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
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24090-450	InnoPran XL	propranolol hydrochloride	Akrimax Pharmaceuticals, LLC	NDA	Current
24090-451	InnoPran XL	propranolol hydrochloride	Akrimax Pharmaceuticals, LLC	NDA	Current
62559-590	InnoPran XL	propranolol hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-590	InnoPran XL	propranolol hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-590	InnoPran XL	propranolol hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-591	InnoPran XL	propranolol hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-591	InnoPran XL	propranolol hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-591	InnoPran XL	propranolol hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-600	Inderal XL	propranolol hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-600	Inderal XL	propranolol hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-600	Inderal XL	propranolol hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-601	Inderal XL	propranolol hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-601	Inderal XL	propranolol hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
62559-601	Inderal XL	propranolol hydrochloride	ANI Pharmaceuticals, Inc.	NDA	Current
76299-420	INDERAL XL	propranolol hydrochloride	Mist Pharmaceuticals, LLC	NDA	Current
76299-422	INDERAL XL	propranolol hydrochloride	Mist Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77155	SUPPL	2023-12-27
77134	SUPPL	2023-12-27
68397	SUPPL	2021-08-18
68387	SUPPL	2021-08-17
36932	SUPPL	2013-11-22
27785	SUPPL	2013-11-20
27784	SUPPL	2010-12-21
5381	SUPPL	2010-12-21
36931	SUPPL	2010-12-16
15473	SUPPL	2010-12-16
15472	SUPPL	2010-01-12
5380	SUPPL	2010-01-05
5379	SUPPL	2008-01-09
36930	SUPPL	2008-01-08
5378	SUPPL	2004-10-29
36929	ORIG	2004-06-07
42166	ORIG	2003-07-08
27783	ORIG	2003-04-15