Home Applications 076939 Application 076939
Type ANDA
Sponsor WATSON LABS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 80MG No No 002 PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 40MG No No 003 PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 20MG No No 004 PRAVASTATIN SODIUM PRAVASTATIN SODIUM TABLET;ORAL 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076939-001 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 A076939-002 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 A076939-003 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 A076939-004 PRAVASTATIN SODIUM PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 164 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 2026-02-19 14:30 UTC 2026-02 A076939-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076939-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076939-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076939-004 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076939-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076939-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076939-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076939-004 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076939-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076939-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076939-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076939-004 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076939-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076939-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076939-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076939-004 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076939-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076939-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076939-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076939-004 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076939-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076939-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076939-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076939-004 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076939-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076939-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076939-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076939-004 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076939-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076939-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076939-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076939-004 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076939-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076939-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076939-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076939-004 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076939-001 PRAVASTATIN SODIUM 80MG TABLET / ORAL AB 2007-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076939-002 PRAVASTATIN SODIUM 40MG TABLET / ORAL AB 2006-10-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076939-003 PRAVASTATIN SODIUM 20MG TABLET / ORAL AB 2006-10-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076939-004 PRAVASTATIN SODIUM 10MG TABLET / ORAL AB 2006-10-23 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 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 1 of 7 · 127 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PRAVASTATIN SODIUM PRAVASTATIN SODIUM Quallent e9c188f7-cd6f-afac-b493-36552d86589e 2026-08-03 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM Apotex Corp. dcf45e4f-b46e-6fbb-b67a-2ff619ab1780 2026-07-31 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM Pravastatin Sodium PRAVASTATIN SODIUM REMEDYREPACK INC. 0c4b59f1-92a8-44f8-8b4c-691f35777460 2026-07-30 Warnings, Adverse reactions Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM Pravastatin sodium PRAVASTATIN SODIUM Aurobindo Pharma Limited b06ed801-ddee-4f56-924a-59fcb451eae6 2026-07-29 Warnings, Adverse reactions Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM REMEDYREPACK INC. e4dbaa72-7b3e-4aef-983b-90efb2b343cd 2026-07-16 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM Pravastatin Sodium PRAVASTATIN SODIUM Cardinal Health 107, LLC ca779f66-4b9d-41da-ad0e-e4f58db9fbac 2026-07-10 Warnings, Adverse reactions Name fallback brand name: Pravastatin Sodium generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM PD-Rx Pharmaceuticals, Inc. c5f611aa-9974-422e-a353-5d834a33937c 2026-07-07 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM PD-Rx Pharmaceuticals, Inc. 8dbdc80d-9d8c-4e22-9108-d87a77e07a6b 2026-07-07 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM Pravastatin sodium PRAVASTATIN SODIUM Safecor Health LLC 0ae196a4-be3d-4cd8-9ff2-68aeb91b8678 2026-07-01 Warnings, Adverse reactions Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM REMEDYREPACK INC. 5ecd9fd1-7662-412d-99c5-13c77188748c 2026-07-01 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM REMEDYREPACK INC. 76e5fdf8-bd03-4cd5-9361-e61678cb3de9 2026-06-26 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM Cardinal Health 107, LLC 3e218ad6-5b47-4cca-81be-ebaea5795964 2026-06-26 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM American Health Packaging 97f826f0-b5c5-410c-b1f0-523873981e8d 2026-06-17 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM Bryant Ranch Prepack ca7a4143-0091-4cd5-9061-cb05cc84ea4e 2026-06-16 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM Pravastatin sodium PRAVASTATIN SODIUM Bryant Ranch Prepack f074240e-ef6b-45f2-8c4d-cb5c0dbc81f1 2026-06-11 Warnings, Adverse reactions Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM Cardinal Health 107, LLC 9289f9ed-b6e3-4e81-bdb8-6aedbd5288a9 2026-06-11 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM Pravastatin sodium PRAVASTATIN SODIUM Bryant Ranch Prepack 3686a2df-51c4-4f1c-9d1e-d69207915144 2026-06-11 Warnings, Adverse reactions Name fallback brand name: Pravastatin sodium generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM Bryant Ranch Prepack 14390bfa-3bcb-43e1-936c-1977cb37427d 2026-06-04 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM Bryant Ranch Prepack 8d1bf7a5-bf11-47e3-afca-dcc13f2d3068 2026-06-04 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM PRAVASTATIN SODIUM PRAVASTATIN SODIUM Bryant Ranch Prepack d0641def-425e-4357-a6b6-24ce00424549 2026-06-01 Warnings, Adverse reactions Name fallback brand name: PRAVASTATIN SODIUM generic name: PRAVASTATIN SODIUM
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 18 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 16252-528 Pravastatin sodium Pravastatin sodium Actavis Pharma, Inc. ANDA Current 21695-178 Pravastatin Sodium Pravastatin Sodium Rebel Distributors Corp ANDA Current 21695-179 Pravastatin Sodium Pravastatin Sodium Rebel Distributors Corp ANDA Current 21695-180 Pravastatin Sodium Pravastatin Sodium Rebel Distributors Corp ANDA Current 50090-2785 Pravastatin sodium Pravastatin sodium A-S Medication Solutions ANDA Current 60760-527 Pravastatin sodium Pravastatin sodium St. Mary's Medical Park Pharmacy ANDA Current 61919-546 PRAVASTATIN SODIUM PRAVASTATIN SODIUM DirectRX ANDA Current 61919-546 PRAVASTATIN SODIUM PRAVASTATIN SODIUM DirectRX ANDA Current 61919-731 PRAVASTATIN SODIUM PRAVASTATIN SODIUM DirectRX ANDA Current 61919-731 PRAVASTATIN SODIUM PRAVASTATIN SODIUM DirectRX ANDA Current 63187-731 Pravastatin sodium Pravastatin sodium Proficient Rx LP ANDA Current 63187-731 Pravastatin sodium Pravastatin sodium Proficient Rx LP ANDA Current 63187-732 Pravastatin sodium Pravastatin sodium Proficient Rx LP ANDA Current 63187-732 Pravastatin sodium Pravastatin sodium Proficient Rx LP ANDA Current 63629-1606 Pravastatin Sodium Pravastatin Sodium Bryant Ranch Prepack ANDA Current 63629-3563 Pravastatin Sodium Pravastatin Sodium Bryant Ranch Prepack ANDA Current 68071-1917 Pravastatin sodium Pravastatin sodium NuCare Pharmaceuticals, Inc. ANDA Current 68071-2194 Pravastatin sodium Pravastatin sodium NuCare Pharmaceuticals, Inc. ANDA Current