Application 062273

Type: ANDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BEEPEN-VK	PENICILLIN V POTASSIUM	TABLET;ORAL	EQ 250MG BASE	No	No
002	BEEPEN-VK	PENICILLIN V POTASSIUM	TABLET;ORAL	EQ 500MG BASE	No	No

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
A062273-001	BEEPEN-VK	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL		Approved before 1982
A062273-002	BEEPEN-VK	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL		Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062273-001	BEEPEN-VK	EQ 250MG BASE	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062273-002	BEEPEN-VK	EQ 500MG BASE	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`

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 3 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals,Inc.	813cc848-11ce-3af0-e053-2991aa0a326f	2024-06-14	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals,Inc.	7ee64c92-7d60-d230-e053-2a91aa0a796e	2024-06-12	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	A-S Medication Solutions	9532c961-2dd6-4e8a-a345-86d57a21c4a3	2024-02-22	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	A-S Medication Solutions	198c4df5-b4ab-49e1-996b-c60f780238bd	2024-02-20	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals,Inc.	0fb8ab8a-5aa7-e6f4-e063-6294a90a1af6	2024-01-24	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	A-S Medication Solutions	b8c3b8f5-bcb3-4f74-8440-54374dfc9974	2023-11-15	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	A-S Medication Solutions	e4642fb3-2db9-49d3-8fd4-ceb750f70437	2023-11-13	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	A-S Medication Solutions	58badf2b-0fb7-4d56-9f47-18b2fdda5199	2023-11-13	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	A-S Medication Solutions	ded0ee2e-56ae-41fe-949c-177614cd8e1f	2023-09-25	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	A-S Medication Solutions	efdda3a5-77d9-4c66-9da7-2be3f3981b79	2023-09-17	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Bryant Ranch Prepack	b6bb14f3-c916-4abd-b967-862eb4f858eb	2023-03-16	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Bryant Ranch Prepack	9fc869b0-1ca5-44b9-ba6e-5bc23544b8de	2023-03-10	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Teva Pharmaceuticals USA, Inc.	3111ca84-6f8e-45ea-91a1-9cb99c63607e	2023-01-31	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	NorthStar Rx LLC	ec25ce45-c0b2-45fa-9211-77f283aad4bd	2022-10-28	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Rising Health, LLC	54b4d087-cfba-4f6b-918c-eaca0003dbd5	2022-10-27	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Aurobindo Pharma Limited	cfc0df21-fb6f-447d-96f6-f851732f9e2f	2022-02-19	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Proficient Rx LP	fbf900f6-0c37-4da6-87e0-cb752e11335f	2021-01-01	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Proficient Rx LP	316aa904-09f1-4a8e-9adf-93cfc14f9a0a	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Proficient Rx LP	e73087af-d485-42e2-8821-51d906e3eeaf	2019-11-01	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN V POTASSIUM

Reported adverse events (FAERS/openFDA)#

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