Home Applications 060733 Application 060733
Type ANDA
Sponsor PHARMACIA AND UPJOHN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BACITRACIN BACITRACIN INJECTABLE;INJECTION 10,000 UNITS/VIAL No No 002 BACITRACIN BACITRACIN INJECTABLE;INJECTION 50,000 UNITS/VIAL No Yes
Source provenance: Browse the complete Orange Book source catalog .
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.
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 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A060733-001 BACITRACIN 10,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A060733-002 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A060733-001 BACITRACIN 10,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A060733-002 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A060733-001 BACITRACIN 10,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A060733-002 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A060733-001 BACITRACIN 10,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A060733-002 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A060733-001 BACITRACIN 10,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A060733-002 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A060733-001 BACITRACIN 10,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A060733-002 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A060733-001 BACITRACIN 10,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A060733-002 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A060733-001 BACITRACIN 10,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A060733-002 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A060733-001 BACITRACIN 10,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A060733-002 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A060733-001 BACITRACIN 10,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A060733-002 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A060733-001 BACITRACIN 10,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A060733-002 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A060733-001 BACITRACIN 10,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A060733-002 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A060733-001 BACITRACIN 10,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A060733-002 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION AP RS, Approved before 1982 ea99ee380514…2022-09-29 23:25 UTC 2022-09 A060733-001 BACITRACIN 10,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 A060733-002 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A060733-001 BACITRACIN 10,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A060733-002 BACITRACIN 50,000 UNITS/VIAL INJECTABLE / INJECTION Approved before 1982 cb3db0bc1861…
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 2 of 2 · 34 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 0009-0233 Bacitracin Bacitracin Pharmacia and Upjohn Company ANDA Current 0009-0233 Bacitracin Bacitracin Pharmacia and Upjohn Company LLC ANDA Current 0009-0233 Bacitracin Bacitracin Pharmacia & Upjohn Company LLC ANDA Current 0009-0233 Bacitracin Bacitracin Pharmacia and Upjohn Company LLC ANDA Current 0009-0233 Bacitracin Bacitracin Pharmacia and Upjohn Company LLC ANDA Current 0009-0233 Bacitracin Bacitracin Pharmacia and Upjohn Company ANDA Current 0009-0233 Bacitracin Bacitracin Pharmacia & Upjohn Company LLC ANDA Current 0009-0233 Bacitracin Bacitracin Pharmacia and Upjohn Company ANDA Current 0009-0233 Bacitracin Bacitracin Pharmacia & Upjohn Company LLC ANDA Current 0009-0234 Bacitracin Bacitracin Pharmacia and Upjohn Company LLC ANDA Current 0009-0234 Bacitracin Bacitracin Pharmacia and Upjohn Company LLC ANDA Current 0009-0234 Bacitracin Bacitracin Pharmacia and Upjohn Company LLC ANDA Current 0009-0241 Bacitracin Bacitracin Pharmacia and Upjohn Company ANDA Current 0009-0241 Bacitracin Bacitracin Pharmacia and Upjohn Company LLC ANDA Current 0009-0241 Bacitracin Bacitracin Pharmacia and Upjohn Company ANDA Current