Application 060657

Type: ANDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PFIZERPEN	PENICILLIN G POTASSIUM	INJECTABLE;INJECTION	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
002	PFIZERPEN	PENICILLIN G POTASSIUM	INJECTABLE;INJECTION	5,000,000 UNITS/VIAL	No	Yes
003	PFIZERPEN	PENICILLIN G POTASSIUM	INJECTABLE;INJECTION	20,000,000 UNITS/VIAL	No	Yes

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	TE codes	RLD / RS
A060657-001	PFIZERPEN	PENICILLIN G POTASSIUM	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982
A060657-002	PFIZERPEN	PENICILLIN G POTASSIUM	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982
A060657-003	PFIZERPEN	PENICILLIN G POTASSIUM	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A060657-002	AP
A060657-003	AP

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	Product TE source text	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060657-002	PFIZERPEN	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060657-003	PFIZERPEN	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060657-001	PFIZERPEN	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060657-002	PFIZERPEN	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060657-003	PFIZERPEN	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060657-001	PFIZERPEN	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060657-002	PFIZERPEN	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060657-003	PFIZERPEN	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A060657-001	PFIZERPEN	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A060657-002	PFIZERPEN	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A060657-003	PFIZERPEN	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060657-001	PFIZERPEN	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060657-002	PFIZERPEN	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060657-003	PFIZERPEN	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A060657-001	PFIZERPEN	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A060657-002	PFIZERPEN	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A060657-003	PFIZERPEN	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A060657-001	PFIZERPEN	1,000,000 UNITS/VIAL	INJECTABLE / INJECTION		Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A060657-002	PFIZERPEN	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A060657-003	PFIZERPEN	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A060657-001	PFIZERPEN	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060657-002	PFIZERPEN	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A060657-003	PFIZERPEN	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A060657-001	PFIZERPEN	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A060657-002	PFIZERPEN	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A060657-003	PFIZERPEN	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A060657-001	PFIZERPEN	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A060657-002	PFIZERPEN	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A060657-003	PFIZERPEN	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A060657-001	PFIZERPEN	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A060657-002	PFIZERPEN	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A060657-003	PFIZERPEN	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A060657-001	PFIZERPEN	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A060657-002	PFIZERPEN	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A060657-003	PFIZERPEN	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A060657-001	PFIZERPEN	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A060657-002	PFIZERPEN	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A060657-003	PFIZERPEN	20,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A060657-001	PFIZERPEN	1,000,000 UNITS/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION		Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A060657-002	PFIZERPEN	5,000,000 UNITS/VIAL	INJECTABLE / INJECTION	AP	RS, Approved before 1982	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A060657-002	AP	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A060657-003	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A060657-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A060657-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A060657-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A060657-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A060657-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A060657-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060657-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A060657-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A060657-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A060657-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060657-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A060657-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060657-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A060657-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A060657-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A060657-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A060657-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A060657-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A060657-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A060657-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A060657-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A060657-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A060657-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A060657-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060657-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A060657-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060657-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A060657-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060657-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A060657-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A060657-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A060657-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060657-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A060657-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A060657-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A060657-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A060657-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A060657-003	AP	1	`4b0b4de00fa7…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pfizerpen	PENICILLIN G POTASSIUM	Roerig	efef4846-9497-41af-8dd6-518f86eca7f2	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060657 application number: ANDA060657 ndc (product): 0049-0520 ndc (product): 0049-0530
Pfizerpen	PENICILLIN G POTASSIUM	Roerig	2f7ea103-56cc-492f-b862-af45f9aed980	2024-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060657 application number: ANDA060657 ndc (product): 0049-0430 ndc (product): 0049-0420
Pfizerpen	PENICILLIN G POTASSIUM	Roerig	d8aaefb6-3f7d-4bc5-b40a-1c58c3054320	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060657 application number: ANDA060657 ndc (product): 0049-0520 ndc (product): 0049-0530

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 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0049-0420	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0420	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0420	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0420	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0430	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0430	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0430	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0430	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0520	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0520	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0520	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0520	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0520	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0520	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0520	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0520	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0520	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0530	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0530	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0530	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0530	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0530	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0530	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0530	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0530	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current
0049-0530	Pfizerpen	penicillin G potassium	Roerig	ANDA	Current