Home Applications 206061 Application 206061
Type ANDA
Sponsor HISUN PHARM HANGZHOU Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 20MG No No 002 PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 40MG No No 003 PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 80MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206061-001 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET / ORAL 2018-11-23 A206061-002 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET / ORAL 2018-11-23 A206061-003 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET / ORAL 2018-11-23
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 4 · 129 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 A206061-001 PRAVASTATIN SODIUM 20MG TABLET / ORAL 2018-11-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206061-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL 2018-11-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206061-003 PRAVASTATIN SODIUM 80MG TABLET / ORAL 2018-11-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206061-001 PRAVASTATIN SODIUM 20MG TABLET / ORAL 2018-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206061-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL 2018-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206061-003 PRAVASTATIN SODIUM 80MG TABLET / ORAL 2018-11-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206061-001 PRAVASTATIN SODIUM 20MG TABLET / ORAL 2018-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206061-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL 2018-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206061-003 PRAVASTATIN SODIUM 80MG TABLET / ORAL 2018-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206061-001 PRAVASTATIN SODIUM 20MG TABLET / ORAL 2018-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206061-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL 2018-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206061-003 PRAVASTATIN SODIUM 80MG TABLET / ORAL 2018-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206061-001 PRAVASTATIN SODIUM 20MG TABLET / ORAL 2018-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206061-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL 2018-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206061-003 PRAVASTATIN SODIUM 80MG TABLET / ORAL 2018-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206061-001 PRAVASTATIN SODIUM 20MG TABLET / ORAL 2018-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206061-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL 2018-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206061-003 PRAVASTATIN SODIUM 80MG TABLET / ORAL 2018-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206061-001 PRAVASTATIN SODIUM 20MG TABLET / ORAL 2018-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206061-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL 2018-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206061-003 PRAVASTATIN SODIUM 80MG TABLET / ORAL 2018-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206061-001 PRAVASTATIN SODIUM 20MG TABLET / ORAL 2018-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206061-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL 2018-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206061-003 PRAVASTATIN SODIUM 80MG TABLET / ORAL 2018-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206061-001 PRAVASTATIN SODIUM 20MG TABLET / ORAL 2018-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206061-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL 2018-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206061-003 PRAVASTATIN SODIUM 80MG TABLET / ORAL 2018-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206061-001 PRAVASTATIN SODIUM 20MG TABLET / ORAL 2018-11-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206061-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL 2018-11-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206061-003 PRAVASTATIN SODIUM 80MG TABLET / ORAL 2018-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206061-001 PRAVASTATIN SODIUM 20MG TABLET / ORAL 2018-11-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206061-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL 2018-11-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206061-003 PRAVASTATIN SODIUM 80MG TABLET / ORAL 2018-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206061-001 PRAVASTATIN SODIUM 20MG TABLET / ORAL 2018-11-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206061-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL 2018-11-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206061-003 PRAVASTATIN SODIUM 80MG TABLET / ORAL 2018-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206061-001 PRAVASTATIN SODIUM 20MG TABLET / ORAL 2018-11-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206061-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL 2018-11-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206061-003 PRAVASTATIN SODIUM 80MG TABLET / ORAL 2018-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206061-001 PRAVASTATIN SODIUM 20MG TABLET / ORAL 2018-11-23 301d65b070ca…
Observed Orange Book normalized TE history# 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 6 of 6 · 118 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PRAVASTATIN SODIUM PRAVASTATIN SODIUM Bryant Ranch Prepack 73633a65-93b9-46dd-8f9f-d4b5c0089040 2024-06-05 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM Bryant Ranch Prepack 24471777-5cd6-4c46-a5f2-a349fadc830e 2024-04-04 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM Pravastatin Sodium PRAVASTATIN SODIUM Direct_Rx 7f814fd9-7b35-67da-e053-2a91aa0a39dc 2024-01-10 Warnings, Adverse reactions Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM Pravastatin Sodium PRAVASTATIN SODIUM Teva Pharmaceuticals USA, Inc. 99e0e848-f8f3-4b42-b880-8fbc42633948 2024-01-01 Warnings, Adverse reactions Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM Lupin Pharmaceuticals, Inc. 1123d56c-16f0-4f81-b56f-67b1f343ae1e 2023-12-19 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM Pravastatin Sodium PRAVASTATIN SODIUM A-S Medication Solutions 4f9ada33-5592-4780-926d-1af49a8e064e 2023-12-15 Warnings, Adverse reactions Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM Pravastatin Sodium PRAVASTATIN SODIUM A-S Medication Solutions a75de063-c751-4647-bb9e-d4050c1e31fc 2023-12-14 Warnings, Adverse reactions Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM Bryant Ranch Prepack 70920620-37d6-4fe0-9d86-1fdffc2e6a99 2023-10-25 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM Proficient Rx LP 4d2b4607-0a46-4b58-9247-dc448ce258ec 2023-08-01 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM Pravastatin Sodium PRAVASTATIN SODIUM Proficient Rx LP 466e2d1a-a6d6-40f8-a9f6-3e7494a34ca6 2023-08-01 Warnings, Adverse reactions Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM Pravastatin Sodium PRAVASTATIN SODIUM A-S Medication Solutions 4948e795-8c33-40e2-ae85-208962daee72 2023-02-06 Warnings, Adverse reactions Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM Pravastatin Sodium PRAVASTATIN SODIUM A-S Medication Solutions 3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d 2023-02-06 Warnings, Adverse reactions Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM Pravastatin Sodium PRAVASTATIN SODIUM Glenmark Pharmaceuticals Inc., USA 6ca01de3-a0f9-4cfb-b36a-723c7c42e2a4 2022-07-08 Warnings, Adverse reactions Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM Pravastatin Sodium PRAVASTATIN SODIUM Teva Pharmaceuticals, Inc. f66cb1c1-5ff1-4b0b-89d0-8ecaee26b0b8 2022-07-01 Warnings, Adverse reactions Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM Aphena Pharma Solutions - Tennessee, LLC ce61f570-2564-429b-8775-157e8e32d378 2022-03-03 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM Proficient Rx LP 2bdfb0ef-2455-4ca2-a117-ce8e26bb2dbc 2022-03-01 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM Proficient Rx LP 63ca6179-6ae3-4f0b-bdca-50d200317921 2019-10-01 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM Pravastatin sodium PRAVASTATIN SODIUM Dr.Reddy's Laboratories Limited 99cc0546-bb2d-751e-edfd-1c15a1182e0c 2018-11-21 Warnings, Adverse reactions Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM
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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42658-105 Pravastatin Sodium Pravastatin Sodium Hisun Pharmaceuiticals USA, Inc ANDA Current 42658-106 Pravastatin Sodium Pravastatin Sodium Hisun Pharmaceuiticals USA, Inc ANDA Current 42658-107 Pravastatin Sodium Pravastatin Sodium Hisun Pharmaceuiticals USA, Inc ANDA Current