Home Applications 218713 Application 218713
Type ANDA
Sponsor KINDOS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 20MG/10ML (2MG/ML) No No 002 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 40MG/20ML (2MG/ML) No No 003 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 100MG/20ML (5MG/ML) No No 004 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 100MG/10ML (10MG/ML) No No 005 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/30ML (5MG/ML) No No 006 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 150MG/20ML (7.5MG/ML) No No 007 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION 200MG/20ML (10MG/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218713-001 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 A218713-002 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 A218713-003 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 A218713-004 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 A218713-005 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 A218713-006 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2024-07-30 A218713-007 ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 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 3 · 98 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 A218713-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218713-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218713-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218713-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218713-005 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218713-006 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2024-07-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218713-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218713-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218713-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218713-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218713-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218713-005 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218713-006 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2024-07-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218713-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218713-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218713-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218713-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218713-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218713-005 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218713-006 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2024-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218713-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218713-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218713-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218713-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218713-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218713-005 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218713-006 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2024-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218713-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218713-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218713-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218713-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218713-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218713-005 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218713-006 ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION / INJECTION AP 2024-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218713-007 ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218713-001 ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218713-002 ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION / INJECTION AP 2024-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218713-003 ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218713-004 ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION / INJECTION AP 2024-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218713-005 ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION / INJECTION AP 2024-07-30 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 98 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.