Application 060711

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	PENICILLIN-VK	PENICILLIN V POTASSIUM	TABLET;ORAL	EQ 250MG BASE	No	No
003	PENICILLIN-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
A060711-002	PENICILLIN-VK	PENICILLIN V POTASSIUM	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982
A060711-003	PENICILLIN-VK	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A060711-002	AB
A060711-003	AB

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	Source SHA-256
2026-09-14 22:38:34	2026-08	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982	`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	A060711-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A060711-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A060711-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A060711-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A060711-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060711-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060711-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060711-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A060711-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060711-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060711-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060711-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060711-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060711-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A060711-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A060711-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A060711-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A060711-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A060711-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A060711-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A060711-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A060711-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A060711-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A060711-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060711-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060711-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060711-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060711-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060711-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060711-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A060711-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A060711-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060711-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060711-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A060711-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A060711-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A060711-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A060711-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A060711-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060711-003	AB	1	`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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Penicillin V Potassium	PENICILLIN V POTASSIUM	REMEDYREPACK INC.	dd8a48b2-9ff1-49de-a53e-db4964c2384c	2026-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060711 application number: ANDA060711
Penicillin V Potassium	PENICILLIN V POTASSIUM	Chartwell RX, LLC	b0744674-ddf7-4022-be2f-2a22bef0d379	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060711 application number: ANDA060711
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals,Inc.	ada3be87-2cdb-75f7-e053-2995a90aa95b	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060711 application number: ANDA060711 ndc (product): 68071-2244
Penicillin V Potassium	PENICILLIN V POTASSIUM	Teva Pharmaceuticals USA, Inc.	3111ca84-6f8e-45ea-91a1-9cb99c63607e	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060711 application number: ANDA060711 ndc (product): 0093-1174 ndc (product): 0093-1172

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-1172	Penicillin V Potassium	Penicillin V Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1172	Penicillin V Potassium	Penicillin V Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1172	Penicillin V Potassium	Penicillin V Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1174	Penicillin V Potassium	Penicillin V Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1174	Penicillin V Potassium	Penicillin V Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-1174	Penicillin V Potassium	Penicillin V Potassium	Teva Pharmaceuticals USA, Inc.	ANDA	Current
10544-500	Penicillin V Potassium	Penicillin V Potassium	Blenheim Pharmacal, Inc.	ANDA	Current
68071-2244	Penicillin V Potassium	Penicillin V Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2244	Penicillin V Potassium	Penicillin V Potassium	NuCare Pharmaceuticals,Inc.	ANDA	Current