Home NDC 70512-036 Gentamicin Sulfate Cream 0.1%
Product NDC 70512-036
11-digit product format 705120036
Labeler code 70512
Product ID 70512-036_a2b5d3ff-920e-280a-e053-2995a90ac84f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gentamicin Sulfate Cream 0.1%
Dosage form CREAM
Route TOPICAL
Labeler Sola Pharmaceuticals
Application ANDA209304
Marketing category ANDA
Marketing start 2020-04-07
Marketing end 0000-00-00
Substance GENTAMICIN SULFATE
Active strength 1 mg/g
Pharmacologic classes Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 2019-12-13 00:20 UTC 2019-12 A209304-001 GENTAMICIN SULFATE EQ 0.1% BASE CREAM / TOPICAL AT 2019-10-18 74a2ff9319b5…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209304-001 GENTAMICIN SULFATE EQ 0.1% BASE CREAM / TOPICAL AT 2019-10-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209304-001 GENTAMICIN SULFATE EQ 0.1% BASE CREAM / TOPICAL AT 2019-10-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209304-001 GENTAMICIN SULFATE EQ 0.1% BASE CREAM / TOPICAL AT 2019-10-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209304-001 GENTAMICIN SULFATE EQ 0.1% BASE CREAM / TOPICAL AT 2019-10-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209304-001 GENTAMICIN SULFATE EQ 0.1% BASE CREAM / TOPICAL AT 2019-10-18 3f01610625f2…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70512-036-30 70512003630 1 TUBE in 1 CARTON (70512-036-30) > 30 g in 1 TUBE 1 tube 2020-04-07 0000-00-00 No No Current