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 1.

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.

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
2026-08-01 22:54:32	2026-06	A060711-002	PENICILLIN-VK	EQ 250MG BASE	TABLET / ORAL	AB	Approved before 1982		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A060711-003	PENICILLIN-VK	EQ 500MG BASE	TABLET / ORAL	AB	Approved before 1982		`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A060711-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A060711-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	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	REMEDYREPACK INC.	dd8a48b2-9ff1-49de-a53e-db4964c2384c	2025-10-02	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