Home Applications 209501 Application 209501
Type NDA
Sponsor PF PRISM CV Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LYRICA CR PREGABALIN TABLET, EXTENDED RELEASE;ORAL 82.5MG Yes No 002 LYRICA CR PREGABALIN TABLET, EXTENDED RELEASE;ORAL 165MG Yes No 003 LYRICA CR PREGABALIN TABLET, EXTENDED RELEASE;ORAL 330MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N209501-001 LYRICA CR PREGABALIN 82.5MG TABLET, EXTENDED RELEASE / ORAL AB RLD 2017-10-11 N209501-002 LYRICA CR PREGABALIN 165MG TABLET, EXTENDED RELEASE / ORAL AB RLD 2017-10-11 N209501-003 LYRICA CR PREGABALIN 330MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2017-10-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 24 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209501-001 10022447 2026-11-02 U-2136 2018-08-16 N209501-001 10022447 2026-11-02 U-2137 2018-08-16 N209501-001 8945620 2026-11-02 U-2136 Drug product 2017-11-09 N209501-001 8945620 2026-11-02 U-2137 Drug product 2017-11-09 N209501-001 9144559 2026-11-02 Drug product 2017-11-09 N209501-001 10022447*PED 2027-05-02 Pediatric extension N209501-001 8945620*PED 2027-05-02 Pediatric extension N209501-001 9144559*PED 2027-05-02 Pediatric extension N209501-002 10022447 2026-11-02 U-2136 2018-08-16 N209501-002 10022447 2026-11-02 U-2137 2018-08-16 N209501-002 8945620 2026-11-02 U-2136 Drug product 2017-11-09 N209501-002 8945620 2026-11-02 U-2137 Drug product 2017-11-09 N209501-002 9144559 2026-11-02 Drug product 2017-11-09 N209501-002 10022447*PED 2027-05-02 Pediatric extension N209501-002 8945620*PED 2027-05-02 Pediatric extension N209501-002 9144559*PED 2027-05-02 Pediatric extension N209501-003 10022447 2026-11-02 U-2136 2018-08-16 N209501-003 10022447 2026-11-02 U-2137 2018-08-16 N209501-003 8945620 2026-11-02 U-2136 Drug product 2017-11-09 N209501-003 8945620 2026-11-02 U-2137 Drug product 2017-11-09 N209501-003 9144559 2026-11-02 Drug product 2017-11-09 N209501-003 10022447*PED 2027-05-02 Pediatric extension N209501-003 8945620*PED 2027-05-02 Pediatric extension N209501-003 9144559*PED 2027-05-02 Pediatric extension
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 4 of 4 · 132 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 2022-10-28 04:53 UTC 2022-10 N209501-001 LYRICA CR 82.5MG TABLET, EXTENDED RELEASE / ORAL AB RLD 2017-10-11 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N209501-002 LYRICA CR 165MG TABLET, EXTENDED RELEASE / ORAL AB RLD 2017-10-11 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N209501-003 LYRICA CR 330MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2017-10-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209501-001 LYRICA CR 82.5MG TABLET, EXTENDED RELEASE / ORAL AB RLD 2017-10-11 e64feba35796…2022-09-29 23:25 UTC 2022-09 N209501-002 LYRICA CR 165MG TABLET, EXTENDED RELEASE / ORAL AB RLD 2017-10-11 e64feba35796…2022-09-29 23:25 UTC 2022-09 N209501-003 LYRICA CR 330MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2017-10-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209501-001 LYRICA CR 82.5MG TABLET, EXTENDED RELEASE / ORAL AB RLD 2017-10-11 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209501-002 LYRICA CR 165MG TABLET, EXTENDED RELEASE / ORAL AB RLD 2017-10-11 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209501-003 LYRICA CR 330MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2017-10-11 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N209501-001 LYRICA CR 82.5MG TABLET, EXTENDED RELEASE / ORAL AB RLD 2017-10-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N209501-002 LYRICA CR 165MG TABLET, EXTENDED RELEASE / ORAL AB RLD 2017-10-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N209501-003 LYRICA CR 330MG TABLET, EXTENDED RELEASE / ORAL AB RLD, RS 2017-10-11 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 108 observed states.
Observed Orange Book patent history# Patent history page 1 of 27 · 1,080 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N209501-001 10022447 2026-11-02 U-2137 2018-08-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-001 10022447 2026-11-02 U-2136 2018-08-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-001 8945620 2026-11-02 U-2136 Drug product 2017-11-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-001 8945620 2026-11-02 U-2137 Drug product 2017-11-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-001 9144559 2026-11-02 Drug product 2017-11-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-001 10022447*PED 2027-05-02 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-001 8945620*PED 2027-05-02 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-001 9144559*PED 2027-05-02 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-002 10022447 2026-11-02 U-2137 2018-08-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-002 10022447 2026-11-02 U-2136 2018-08-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-002 8945620 2026-11-02 U-2137 Drug product 2017-11-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-002 8945620 2026-11-02 U-2136 Drug product 2017-11-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-002 9144559 2026-11-02 Drug product 2017-11-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-002 10022447*PED 2027-05-02 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-002 8945620*PED 2027-05-02 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-002 9144559*PED 2027-05-02 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-003 10022447 2026-11-02 U-2137 2018-08-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-003 10022447 2026-11-02 U-2136 2018-08-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-003 8945620 2026-11-02 U-2137 Drug product 2017-11-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-003 8945620 2026-11-02 U-2136 Drug product 2017-11-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-003 9144559 2026-11-02 Drug product 2017-11-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-003 10022447*PED 2027-05-02 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-003 8945620*PED 2027-05-02 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N209501-003 9144559*PED 2027-05-02 Pediatric extension c2088c7a36db…2026-09-14 22:38:34 2026-08 N209501-001 10022447 2026-11-02 U-2137 2018-08-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209501-001 10022447 2026-11-02 U-2136 2018-08-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209501-001 8945620 2026-11-02 U-2136 Drug product 2017-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209501-001 8945620 2026-11-02 U-2137 Drug product 2017-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209501-001 9144559 2026-11-02 Drug product 2017-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209501-001 10022447*PED 2027-05-02 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209501-001 8945620*PED 2027-05-02 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209501-001 9144559*PED 2027-05-02 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209501-002 10022447 2026-11-02 U-2137 2018-08-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209501-002 10022447 2026-11-02 U-2136 2018-08-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209501-002 8945620 2026-11-02 U-2137 Drug product 2017-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209501-002 8945620 2026-11-02 U-2136 Drug product 2017-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209501-002 9144559 2026-11-02 Drug product 2017-11-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209501-002 10022447*PED 2027-05-02 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209501-002 8945620*PED 2027-05-02 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209501-002 9144559*PED 2027-05-02 Pediatric extension 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 45 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 1 · 1 matching rows.
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 · 15 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0071-1026 Lyrica CR PREGABALIN Parke-Davis Div of Pfizer Inc NDA Current 0071-1026 Lyrica CR PREGABALIN Parke-Davis Div of Pfizer Inc NDA Current 0071-1026 Lyrica CR PREGABALIN Parke-Davis Div of Pfizer Inc NDA Current 0071-1026 Lyrica CR PREGABALIN Parke-Davis Div of Pfizer Inc NDA Current 0071-1027 Lyrica CR PREGABALIN Parke-Davis Div of Pfizer Inc NDA Current 0071-1027 Lyrica CR PREGABALIN Parke-Davis Div of Pfizer Inc NDA Current 0071-1027 Lyrica CR PREGABALIN Parke-Davis Div of Pfizer Inc NDA Current 0071-1027 Lyrica CR PREGABALIN Parke-Davis Div of Pfizer Inc NDA Current 0071-1029 Lyrica CR PREGABALIN Parke-Davis Div of Pfizer Inc NDA Current 0071-1029 Lyrica CR PREGABALIN Parke-Davis Div of Pfizer Inc NDA Current 0071-1029 Lyrica CR PREGABALIN Parke-Davis Div of Pfizer Inc NDA Current 0071-1029 Lyrica CR PREGABALIN Parke-Davis Div of Pfizer Inc NDA Current 63539-024 Lyrica CR PREGABALIN U.S. Pharmaceuticals NDA Current 63539-024 Lyrica CR PREGABALIN U.S. Pharmaceuticals NDA Current 63539-024 Lyrica CR PREGABALIN U.S. Pharmaceuticals NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 82105 SUPPL 2025-05-01 82060 SUPPL 2025-04-29 82059 SUPPL 2025-04-29 76825 SUPPL 2024-04-10 76793 SUPPL 2024-01-08 62517 SUPPL 2020-04-09 62445 SUPPL 2020-04-06 56106 ORIG 2018-10-26 50021 ORIG 2017-10-12 50018 ORIG 2017-10-12 50017 ORIG 2017-10-12