Home Applications 062935 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 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 A062935-001 PENICILLIN V POTASSIUM EQ 500MG BASE TABLET / ORAL AB 1988-11-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A062935-001 PENICILLIN V POTASSIUM EQ 500MG BASE TABLET / ORAL AB 1988-11-23 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium 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 brand name: Penicillin V Potassium generic name: PENICILLIN V POTASSIUM
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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