Home Applications 013684 Application 013684
Type NDA
Sponsor BAXTER HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OSMITROL 5% IN WATER MANNITOL INJECTABLE;INJECTION 5GM/100ML No No 002 OSMITROL 10% IN WATER MANNITOL INJECTABLE;INJECTION 10GM/100ML No No 003 OSMITROL 20% IN WATER MANNITOL INJECTABLE;INJECTION 20GM/100ML No No 004 OSMITROL 15% IN WATER MANNITOL INJECTABLE;INJECTION 15GM/100ML No No 005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 5GM/100ML No No 006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 10GM/100ML No No 007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 20GM/100ML No No 008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER MANNITOL INJECTABLE;INJECTION 15GM/100ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 8 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N013684-001 OSMITROL 5% IN WATER MANNITOL 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-002 OSMITROL 10% IN WATER MANNITOL 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-003 OSMITROL 20% IN WATER MANNITOL 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-004 OSMITROL 15% IN WATER MANNITOL 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER MANNITOL 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER MANNITOL 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER MANNITOL 20GM/100ML INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER MANNITOL 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 8 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 4 of 9 · 352 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 2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N013684-001 OSMITROL 5% IN WATER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N013684-002 OSMITROL 10% IN WATER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N013684-003 OSMITROL 20% IN WATER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N013684-004 OSMITROL 15% IN WATER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N013684-001 OSMITROL 5% IN WATER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N013684-002 OSMITROL 10% IN WATER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N013684-003 OSMITROL 20% IN WATER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N013684-004 OSMITROL 15% IN WATER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N013684-001 OSMITROL 5% IN WATER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N013684-002 OSMITROL 10% IN WATER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N013684-003 OSMITROL 20% IN WATER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N013684-004 OSMITROL 15% IN WATER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N013684-001 OSMITROL 5% IN WATER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N013684-002 OSMITROL 10% IN WATER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N013684-003 OSMITROL 20% IN WATER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N013684-004 OSMITROL 15% IN WATER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N013684-001 OSMITROL 5% IN WATER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N013684-002 OSMITROL 10% IN WATER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N013684-003 OSMITROL 20% IN WATER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N013684-004 OSMITROL 15% IN WATER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N013684-005 OSMITROL 5% IN WATER IN PLASTIC CONTAINER 5GM/100ML INJECTABLE / INJECTION AP Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N013684-006 OSMITROL 10% IN WATER IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N013684-007 OSMITROL 20% IN WATER IN PLASTIC CONTAINER 20GM/100ML INJECTABLE / INJECTION AP Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N013684-008 OSMITROL 15% IN WATER IN PLASTIC CONTAINER 15GM/100ML INJECTABLE / INJECTION AP Approved before 1982 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 9 · 352 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 · 17 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0338-0351 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current 0338-0351 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current 0338-0353 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current 0338-0353 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current 0338-0353 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current 0338-0353 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current 0338-0353 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current 0338-0355 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current 0338-0355 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current 0338-0355 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current 0338-0355 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current 0338-0355 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current 0338-0357 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current 0338-0357 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current 0338-0357 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current 0338-0357 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current 0338-0357 Osmitrol Mannitol Baxter Healthcare Corporation NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 59583 SUPPL 2019-08-06 59604 SUPPL 2019-08-05 56544 SUPPL 2018-11-23 56543 SUPPL 2018-11-23 56488 SUPPL 2018-11-16 56486 SUPPL 2018-11-16 12053 SUPPL 2005-09-07 10833 SUPPL 2005-09-07 33108 SUPPL 2005-06-14 12052 SUPPL 2005-06-14