Application 070690

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	SOLUTION;ORAL	40MG/5ML	No	Yes
002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	SOLUTION;ORAL	20MG/5ML	No	Yes

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

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
A070690-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15
A070690-002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	AA	RS	1987-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070690-002	AA

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 2 · 44 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
2026-08-18 06:07:40	2026-07	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070690-002	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	AA	RS	1987-05-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070690-001	PROPRANOLOL HYDROCHLORIDE	40MG/5ML	SOLUTION / ORAL		RS	1987-05-15	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A070690-002	AA	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A070690-002	AA	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070690 application number: ANDA070690 ndc (product): 0054-3730

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-3730	Propranolol Hydrochloride	Propranolol Hydrochloride	West Ward Pharmaceuticals Corp.	ANDA	Current
0054-3730	Propranolol Hydrochloride	Propranolol Hydrochloride	West Ward Pharmaceuticals Corp.	ANDA	Current