Application 060014
- Type
- NDA
- Sponsor
- CASPER PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PERMAPEN | PENICILLIN G BENZATHINE | INJECTABLE;INJECTION | 600,000 UNITS/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N060014-001 | PERMAPEN | PENICILLIN G BENZATHINE | 600,000 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N060014-001 | PERMAPEN | 600,000 UNITS/ML | INJECTABLE / INJECTION | Approved before 1982 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BICILLIN L-A | PENICILLIN G BENZATHINE | Pfizer Laboratories Div Pfizer Inc | 012d46f1-d0a0-4676-a879-cd320297ab16 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | PENICILLIN G BENZATHINE |
| BICILLIN L-A | PENICILLIN G BENZATHINE | A-S Medication Solutions | a519a9bf-8fec-4fd3-b0b2-f4ae8c7f20ce | 2023-10-24 | Boxed warning, Warnings, Adverse reactions | PENICILLIN G BENZATHINE |