Application 062935

Type: ANDA
Sponsor: DAVA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PENICILLIN V POTASSIUM	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062935-001	PENICILLIN V POTASSIUM	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB		1988-11-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062935-001	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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062935-001	PENICILLIN V POTASSIUM	EQ 500MG BASE	TABLET / ORAL	AB	1988-11-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062935-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062935-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062935-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062935-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062935-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062935-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062935-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062935-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062935-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062935-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062935-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062935-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062935-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062935-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062935-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062935-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062935-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062935-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062935-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062935-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062935-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062935-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062935-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062935-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062935-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062935-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062935-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062935-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062935-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062935-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062935-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062935-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062935-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062935-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062935-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062935-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062935-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062935-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062935-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062935-001	AB	1	`cb3db0bc1861…`

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 3 · 58 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.	fba1ffe5-809a-495b-bf3e-f2099ac459f6	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	REMEDYREPACK INC.	8f9fa2c8-4d25-48a8-9257-43c33d08e83a	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	REMEDYREPACK INC.	b5972712-f735-46ed-a94a-b84668bb6a82	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Chartwell RX, LLC	b0744674-ddf7-4022-be2f-2a22bef0d379	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Redpharm Drug	546c367a-c786-8326-e063-6294a90ae76c	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Proficient Rx LP	b8f797fb-979c-4eab-a3a6-ad4edcb9ff07	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	REMEDYREPACK INC.	5f0759cc-c553-49b9-9049-80e713758958	2026-04-09	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Bryant Ranch Prepack	609c3e26-9220-4f3c-b393-a2b41b68de6c	2026-03-12	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	QPharma Inc	8c11af69-146f-47ed-b12a-7b201fec7e50	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	ceddc406-4a17-471f-917e-63b4b03779ea	2025-10-17	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	9bc7006d-a482-47c4-a138-5380ce927812	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	4ad879d4-eb32-49f0-af73-c47fc7581936	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	450ad3aa-7c9e-497b-b00e-b1af0322f8d0	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	0151c742-7525-4707-af03-bd48d50cd586	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	281f9c32-e28a-46ae-9e4e-c2143aaa6c6b	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	aa90bf0b-c08d-43e5-b247-1a5c5e3c94e4	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	a251a769-280e-4024-ad7a-317746325818	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	PD-Rx Pharmaceuticals, Inc.	73cd20d5-2521-4b93-a221-fa3fe490eba6	2025-10-08	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	REMEDYREPACK INC.	dd8a48b2-9ff1-49de-a53e-db4964c2384c	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Penicillin V Potassium	PENICILLIN V POTASSIUM	Bryant Ranch Prepack	bdffe8fe-e6e0-4c08-894c-0653605ff433	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-8056	Penicillin V Potassium	Penicillin V Potassium	Liberty Pharmaceuticals, Inc.	ANDA	Current
10544-297	Penicillin V Potassium	Penicillin V Potassium	Blenheim Pharmacal, Inc.	ANDA	Current
21695-318	Penicillin V Potassium	Penicillin V Potassium	Rebel Distributors Corp	ANDA	Current
33261-138	Penicillin V Potassium	Penicillin V Potassium	Aidarex Pharmaceuticals LLC	ANDA	Current
43063-096	Penicillin V Potassium	Penicillin V Potassium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
51655-011	Penicillin V Potassium	Penicillin V Potassium	Northwind Pharmaceuticals	ANDA	Current
55700-044	Penicillin V Potassium	Penicillin V Potassium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60429-148	Penicillin V Potassium	Penicillin V Potassium	Golden State Medical Supply, Inc.	ANDA	Current
60429-148	Penicillin V Potassium	Penicillin V Potassium	Golden State Medical Supply, Inc.	ANDA	Current
63187-045	Penicillin V Potassium	Penicillin V Potassium	Proficient Rx LP	ANDA	Current
63187-045	Penicillin V Potassium	Penicillin V Potassium	Proficient Rx LP	ANDA	Current
66267-809	Penicillin V Potassium	Penicillin V Potassium	NuCare Pharmaceuticals, Inc.	ANDA	Current
66267-809	Penicillin V Potassium	Penicillin V Potassium	NuCare Pharmaceuticals, Inc.	ANDA	Current
67253-201	Penicillin V Potassium	Penicillin V Potassium	Par Pharmaceutical	ANDA	Current
67253-201	Penicillin V Potassium	Penicillin V Potassium	Par Pharmaceutical	ANDA	Current
67296-0332	Penicillin V Potassium	Penicillin V Potassium	RedPharm Drug, Inc.	ANDA	Current
67296-0332	Penicillin V Potassium	Penicillin V Potassium	RedPharm Drug, Inc.	ANDA	Current