Application 060392

Type: ANDA
Sponsor: APOTHECON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	TABLET;ORAL	250,000 UNITS	No	No
004	PENTIDS '400'	PENICILLIN G POTASSIUM	TABLET;ORAL	400,000 UNITS	No	No
005	PENTIDS '800'	PENICILLIN G POTASSIUM	TABLET;ORAL	800,000 UNITS	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
A060392-003	PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	250,000 UNITS	TABLET / ORAL	Approved before 1982
A060392-004	PENTIDS '400'	PENICILLIN G POTASSIUM	400,000 UNITS	TABLET / ORAL	Approved before 1982
A060392-005	PENTIDS '800'	PENICILLIN G POTASSIUM	800,000 UNITS	TABLET / ORAL	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.

Product history page 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060392-004	PENTIDS '400'	400,000 UNITS	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060392-005	PENTIDS '800'	800,000 UNITS	TABLET / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060392-003	PENICILLIN G POTASSIUM	250,000 UNITS	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060392-004	PENTIDS '400'	400,000 UNITS	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060392-005	PENTIDS '800'	800,000 UNITS	TABLET / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060392-003	PENICILLIN G POTASSIUM	250,000 UNITS	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060392-004	PENTIDS '400'	400,000 UNITS	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060392-005	PENTIDS '800'	800,000 UNITS	TABLET / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A060392-003	PENICILLIN G POTASSIUM	250,000 UNITS	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A060392-004	PENTIDS '400'	400,000 UNITS	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A060392-005	PENTIDS '800'	800,000 UNITS	TABLET / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060392-003	PENICILLIN G POTASSIUM	250,000 UNITS	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060392-004	PENTIDS '400'	400,000 UNITS	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060392-005	PENTIDS '800'	800,000 UNITS	TABLET / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A060392-003	PENICILLIN G POTASSIUM	250,000 UNITS	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A060392-004	PENTIDS '400'	400,000 UNITS	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A060392-005	PENTIDS '800'	800,000 UNITS	TABLET / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A060392-003	PENICILLIN G POTASSIUM	250,000 UNITS	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A060392-004	PENTIDS '400'	400,000 UNITS	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A060392-005	PENTIDS '800'	800,000 UNITS	TABLET / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A060392-003	PENICILLIN G POTASSIUM	250,000 UNITS	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060392-004	PENTIDS '400'	400,000 UNITS	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060392-005	PENTIDS '800'	800,000 UNITS	TABLET / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A060392-003	PENICILLIN G POTASSIUM	250,000 UNITS	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A060392-004	PENTIDS '400'	400,000 UNITS	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A060392-005	PENTIDS '800'	800,000 UNITS	TABLET / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A060392-003	PENICILLIN G POTASSIUM	250,000 UNITS	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A060392-004	PENTIDS '400'	400,000 UNITS	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A060392-005	PENTIDS '800'	800,000 UNITS	TABLET / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A060392-003	PENICILLIN G POTASSIUM	250,000 UNITS	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A060392-004	PENTIDS '400'	400,000 UNITS	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A060392-005	PENTIDS '800'	800,000 UNITS	TABLET / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A060392-003	PENICILLIN G POTASSIUM	250,000 UNITS	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A060392-004	PENTIDS '400'	400,000 UNITS	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A060392-005	PENTIDS '800'	800,000 UNITS	TABLET / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A060392-003	PENICILLIN G POTASSIUM	250,000 UNITS	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A060392-004	PENTIDS '400'	400,000 UNITS	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A060392-005	PENTIDS '800'	800,000 UNITS	TABLET / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A060392-003	PENICILLIN G POTASSIUM	250,000 UNITS	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A060392-004	PENTIDS '400'	400,000 UNITS	TABLET / ORAL	Approved before 1982	`c0c555d07b60…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PENICILLIN G POTASSIUM	PENICILLIN G	Baxter Healthcare Corporation	9e58122f-5c75-4905-a774-d3a4dae4ff8c	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: PENICILLIN G POTASSIUM
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	HF Acquisition Co LLC, DBA HealthFirst	56ab659e-ad28-028f-e063-6394a90a6943	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: PENICILLIN G POTASSIUM generic name: PENICILLIN G POTASSIUM
PENICILLIN G POTASSIUM	PENICILLIN G POTASSIUM	HF Acquisition Co LLC, DBA HealthFirst	50c7500f-be06-01af-e063-6294a90a0135	2026-05-01	Warnings, Adverse reactions	Name fallback brand name: PENICILLIN G POTASSIUM generic name: PENICILLIN G POTASSIUM
Pfizerpen	PENICILLIN G POTASSIUM	Roerig	efef4846-9497-41af-8dd6-518f86eca7f2	2025-12-16	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN G POTASSIUM
Penicillin G Potassium	PENICILLIN G POTASSIUM	Avenacy Inc.	969a421e-37d8-499e-9e89-67e210bd5d9d	2025-02-01	Warnings, Adverse reactions	Name fallback brand name: Penicillin G Potassium generic name: PENICILLIN G POTASSIUM
Penicillin G Potassium	PENICILLIN G POTASSIUM	Athenex Pharmaceutical Division, LLC.	1442486a-05d6-4dce-8b95-857a30f478c2	2025-01-28	Warnings, Adverse reactions	Name fallback brand name: Penicillin G Potassium generic name: PENICILLIN G POTASSIUM
Pfizerpen	PENICILLIN G POTASSIUM	Roerig	2f7ea103-56cc-492f-b862-af45f9aed980	2024-12-12	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN G POTASSIUM
Pfizerpen	PENICILLIN G POTASSIUM	Roerig	d8aaefb6-3f7d-4bc5-b40a-1c58c3054320	2024-12-10	Warnings, Adverse reactions	Name fallback generic name: PENICILLIN G POTASSIUM
Penicillin G Potassium	PENICILLIN G POTASSIUM	Sagent Pharmaceuticals	fb2f3afe-0072-4383-bad8-9da9e94db4f2	2024-12-04	Warnings, Adverse reactions	Name fallback brand name: Penicillin G Potassium generic name: PENICILLIN G POTASSIUM
Penicillin G Potassium	PENICILLIN G POTASSIUM	NorthStar Rx, LLC	8732b7ff-2e47-4f99-aadf-81861b431f4f	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Penicillin G Potassium generic name: PENICILLIN G POTASSIUM
Penicillin G Potassium	PENICILLIN G POTASSIUM	Sandoz Inc	91950983-4884-40d1-abd8-bcc953d61b7f	2020-09-16	Warnings, Adverse reactions	Name fallback brand name: Penicillin G Potassium generic name: PENICILLIN G POTASSIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.